# Traumatic Brain Injury Surveillance and Traumatic Brain Injury Follow-up Registries

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URL: https://www.frixlaw.com/law-library/documents/fr%3A98-5389

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** March 3, 1998
- **Citation:** 63 FR 10385

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 98022]

Traumatic Brain Injury Surveillance and Traumatic Brain Injury
Follow-up Registries

Introduction

The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1998 funds for a cooperative agreement
program for population-based data systems for Traumatic Brain Injury
(TBI). The program will serve two purposes:

Part I--To support or enhance existing State surveillance systems for
TBI to ensure they are population-based and provide high quality,
useful data.
Part II--To develop or enhance population-based registries of persons
sustaining TBI to better define the outcomes and secondary conditions
associated with the injury.

CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a national activity
to reduce morbidity and mortality and to improve the quality of life.
This announcement is related to the priority areas of Unintentional
Injuries, Violent and Abusive Behavior, and Surveillance and Data
Systems. (For ordering a copy of ``Healthy People 2000,'' see the
section Where to Obtain Additional Information.)

Authority

This program is authorized under sections 301, 317, 391-394a, of
the Public Health Service Act (42 U.S.C. 241, 247b, 280b-1 and 280b-2)
as amended, and supported by Public Law 104-166.

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.

Eligible Applicants

Eligible applicants are the official public health agencies of
States or their bona fide agents. This includes the District of
Columbia, American Samoa, the Commonwealth of Puerto Rico, the Virgin
Islands, the Federated States of Micronesia, Guam, the Northern Mariana
Islands, the Republic of the Marshall Islands and the Republic of
Palau.
State agencies applying under this announcement that are other than
the official State health department must provide written concurrence
for the application from the official State health department.
For each part of this announcement, only one application per Part,
from each State, may enter the review process and be considered for an
award under this program.
Applicants may apply for Part I only or for Part I and Part II or
for Part II only.
Priority preferences for Part I will be given to competing-
continuation applicants who were funded under Announcement 526, who
currently participate in CDC's multi-State TBI surveillance system,
i.e., States that have provided population-based TBI data to CDC for
cases incident in years 1994 or later.

Note: Public Law 104-65, dated December 19, 1995, states that an
organization described in section 501(c)(4) of the IRS Code of 1986,
which engages in lobbying activities, shall not be eligible for the
receipt of Federal funds constituting an award, a grant, contract,
loan, or any other form.

[[Page 10386]]

Availability of Funds

Approximately $1,310,000 is available in FY 1998 to fund
approximately six awards under Parts I and II of this announcement:

Part I--Up to $550,000 is available in FY 1998 to fund up to four
awards to support or enhance existing State surveillance systems for
TBI. It is expected that the average award will be in the range of
$125,000--$135,000.
Part II--Up to $760,000 is available in FY 1998 to fund two awards to
develop or enhance population-based registries of persons with TBI,
including initial efforts addressing persons treated in emergency
departments for TBI but not hospitalized. It is expected that the
average award will be $380,000.

Both Part I and Part II projects are expected to begin on or about
August 1, 1998, and will be made for a 12-month budget period within a
project period of up to three years. Funding estimates may vary and are
subject to change. Cooperative agreement funds cannot be used to
replace other existing funds for TBI surveillance or registry
activities.
Continuation awards within the project period will be made on the
basis of satisfactory performance and the availability of funds.

Use of Funds

Restriction on Lobbying

Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. 1352 (which has been in effect since December
23, 1989), recipients (and their subtier contractors) are prohibited
from using appropriated Federal funds (other than profits from a
Federal contract) for lobbying Congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1998 Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act (Pub.
L. 105-78) states in section 503 (a) and (b) that no part of any
appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relationships, for
publicity or propaganda purposes, for the preparation, distribution, or
use of any kit, pamphlet, booklet, publication, radio, television, or
video presentation designed to support or defeat legislation pending
before the Congress or any State legislature, except in presentation to
the Congress or any State legislature itself. No part of any
appropriation contained in this Act shall be used to pay the salary or
expenses of any grant or contract recipient, or agent acting for such
recipient, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature.

Prohibition on Use of CDC Funds for Certain Gun Control Activities

The Departments of Labor, Health and Human Services, and Education,
and Related Agencies Appropriations Act, 1998 specifies that: ``None of
the funds made available for injury prevention and control at the
Centers for Disease Control and Prevention may be used to advocate or
promote gun control.'' Anti-Lobbying Act requirements prohibit lobbying
Congress with appropriated Federal monies. Specifically, this Act
prohibits the use of Federal funds for direct or indirect
communications intended or designed to influence a member of Congress
with regard to specific Federal legislation. This prohibition includes
the funding and assistance of public grassroots campaigns intended or
designed to influence members of Congress with regard to specific
legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, CDC
interprets the new language in the CDC's 1998 Appropriations Act to
mean that CDC's funds may not be spent on political action or other
activities designed to affect the passage of specific Federal, State,
or local legislation intended to restrict or control the purchase or
use of firearms.

Background & Definitions

Background

Among all types of injury, traumatic brain injury is most likely to
result in death or permanent disability. The incidence and prevalence,
severity, and cost of TBI indicate its importance as a public health
problem.
A. Some estimates and studies of incidence have indicated that
traumatic brain injuries may result in more than 500,000 emergency
department visits, 260,000 hospitalizations and more than 51,000 deaths
each year in the United States.
B. The severity of the nonfatal injuries is shown by estimates that
each year 70,000 to 90,000 people sustain TBI resulting in permanent
disability.
C. The costs of TBI--acute care, rehabilitation, chronic care, and
indirect costs--are unknown but certainly enormous. One estimate
suggests that head injuries impose an annual economic burden of $37
billion in direct and indirect costs. These estimates of cost fail to
account for the extraordinary losses experienced by the families and
friends of those who have died or sustained disability from TBI.
D. TBI is largely preventable. The leading causes of TBI are motor-
vehicle crashes, falls, and violence.
State-based Surveillance. Over the past several years, many States
have responded to the need for better TBI data by developing public
health surveillance systems. These data systems are beginning to
provide ongoing population-based incidence and etiologic information
that is useful to plan and evaluate public health programs. Building on
these efforts, CDC funded four States in 1995 (Announcement 526) and
eleven more States in 1997 (Announcement 526) to conduct ongoing
population-based TBI surveillance.
Methods of data collection vary among these surveillance systems.
All obtain mortality data from State vital records or multiple-cause-
of-death data files. Data on hospitalizations for TBI are obtained by
several mechanisms: Employing legal reporting requirements for CNS
injuries similar to reporting requirements for certain communicable
diseases, using existing hospital discharge data systems or trauma
registries, or relying on a combination of these methods. Changes in
health care practices in the United States in recent years have
resulted in a smaller proportion of persons with TBI being admitted to
hospitals after evaluation in emergency departments. To assess the
public health importance of TBIs increasingly being treated only in
emergency departments, a few States are developing methods to expand
TBI surveillance to include emergency department-based care.
Lack of information about outcomes of TBI. Although there are
increasing data to describe the current incidence and etiology of TBI,
little is known, on a population basis, about the outcomes experienced
by persons who survive traumatic brain injury. These outcomes include:
their impairments, disabilities (functional limitations), and handicaps
(e.g., limits in ability to return to full social participation
including major roles such as work or school); the occurrence of
secondary conditions; and the need for and use of post-acute

[[Page 10387]]

medical, rehabilitation, and social 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 specific impairments
associated with disabling injuries could lead to improving acute care
and rehabilitation interventions aimed at reducing the severity of
impairment and related disabilities. Third, little is known about
barriers to receiving needed rehabilitation and other health-related
services following TBI. In 1995, under Announcement 526--Part II, CDC
funded one State (Colorado) to develop a population-based registry of
persons with TBI to assess the outcomes they experience and their need
for services in the year following injury.
Additionally, there is a critical lack of information about
outcomes experienced by persons who experience a TBI which does not
result in hospitalization. Critical work is needed to evaluate the
quality of emergency department data for TBI surveillance, to define
relevant public health outcome measures for persons with TBI who are
not hospitalized, and to develop methods to collect outcome data among
this group.

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 the sections: Where to Obtain Additional Information
and Traumatic Brain Injury Surveillance References.
Surveillance is the ongoing, systematic collection, analysis, and
interpretation of health data necessary for designing, implementing,
and evaluating public health programs.
Hospital discharge data (HDD) are summary data compiled by
hospitals for all patients admitted and discharged. These data, which
are usually entered in a computer data base maintained by each
hospital, include information on patient age, sex, residence, diagnoses
coded according to the International Classification of Diseases, 9th
Revision, Clinical Modification (ICD-9-CM codes), services provided,
service charges, and dates of hospital admission and discharge. In some
jurisdictions, hospital discharge data are compiled from all patients
in all hospitals and are maintained in a centralized, population-based,
data collection system. In other jurisdictions, these data are
separately maintained by each hospital.
Hospital emergency departments (ED's) are defined as facilities
offering 24-hour emergency medical services affiliated with an acute
care hospital of six or more beds.
Impairment refers to loss or abnormality of an organ, extremity,
tissue, or other body part such as an amputated or paralyzed extremity.
Disability (functional limitation) refers to a restriction or lack
of ability to perform an action or activity considered normal for a
human being, such as walking.
Handicap refers to a disadvantage for a given individual, resulting
from impairment or disability, that limits or prevents the fulfilment
of a role that is considered normal for that individual. See World
Health Organization, International Classification of Impairments,
Disabilities, and Handicaps, Geneva, 1980.
A secondary condition is a disease, impairment, or disability that
occurs at an increased frequency among people with a primary disabling
condition. See Institute of Medicine, Disability in America--Toward a
National Agenda for Prevention, National Academy Press, Washington
1991.
Timeliness refers to the promptness with which surveillance systems
gather, analyze, and report information gathered. For purposes of the
multi State TBI surveillance system related to this program, TBI case-
level data should be submitted to CDC in less than 18 months from the
end of each calendar year under surveillance.
A population-based registry is defined as a system of ongoing
registration of 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. (adapted from Last JM. A Dictionary of
Epidemiology, Oxford University Press, New York, 1988.)

Purpose

The purpose of this program is to promote the quality and
availability of TBI data:

Part I--To support or enhance existing State TBI surveillance systems,
in order to promote a multi-State surveillance system that uses common
case definitions and data elements according to CDC's Guidelines for
Central Nervous System Injury Surveillance. This multi-State
surveillance system is defining the magnitude of TBI at a national
level, defining the spectrum of severity of injury, helping to identify
populations at high risk, and defining the distribution of external
causes of injury, in order to plan injury control programs addressing
prevention and service provision.
Part II--To develop or enhance population-based data collection methods
to define the longer term public health impacts of TBI--examining the
outcomes of TBI (impairments, disabilities, and handicaps). Part II is
intended to support the development or enhancement of pilot registries
that assess persons six to 12 months following hospitalization for TBI.
It is expected that Part II recipients will build on experience gained
and methods developed by the Colorado Department of Health and
Environment/Craig Hospital Project, funded under P.A. 526. Part II.
Additionally, Part II funding will support activities to evaluate the
quality of emergency department data for TBI surveillance and initiate
the development of methods to assess outcomes among persons treated for
TBI in hospital EDs but not hospitalized.

Application Requirements

Part I--Eligible applicants must:
1. Demonstrate the existence of a population-based TBI surveillance
system Statewide or a population-based TBI surveillance system in a
geopolitical jurisdiction of the State of 1.5 million people or more.
2. Demonstrate the availability of at least one year of TBI data
from the TBI surveillance system (either calendar year 1995 or 1996
data).
3. Document that legislation and/or regulations are in place that
support current collection of TBI data, and that confidentiality is
protected.
Part II--Eligible applicants must:
1. Apply for funding under Part I of this announcement, or
currently be funded under Announcement 716.
2. Demonstrate that data are collected with personal identifiers
including names.
3. Document that legislation and/or regulations are in place that
allow follow-up of persons with TBI.
4. Demonstrate that the population targeted for follow-up is either
Statewide or in a geopolitical jurisdiction of the State of 1.5 million
people or more.
An affirmative response to each requirement is necessary for the
full objective review of applications under Part I or II. The applicant
must provide this documentation on a separate page

[[Page 10388]]

to be included as the first page of the application, entitled:
``Application Requirements Declaration.''

Cooperative Activities

In conducting activities to achieve the purposes of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC will be responsible for the activities
listed under B. (CDC Activities) below.

Part I

Recipients of awards under Part I of this announcement will conduct
population-based TBI surveillance Statewide or in a population defined
by a geopolitical jurisdiction of the State of 1.5 million or more.
A. Recipient Activities include but will not be limited to:
1. Conduct Statewide surveillance of TBI using the definitions,
data elements, and methods described in the CDC Guidelines for Central
Nervous System Injury Surveillance. Recipients will collect information
addressing diagnosis, demographics, etiology, severity, and outcome as
defined in section Application Content of this announcement. Recipients
are expected to link data obtained from State vital records (death
certificates and/or multiple-cause-of-death data) and hospital
discharge data, to produce a non-duplicative data set for the
population under surveillance. Since hospital discharge data and vital
records may not contain complete information describing injury cause,
circumstances, severity, and outcome, recipients are expected to obtain
additional data from hospital medical records and/or medical examiner/
coroner reports in either all cases or a representative sample of
cases.
2. Evaluate the surveillance system for completeness and validity
of data collected.
3. Develop and submit an annual report to CDC on the analysis of
surveillance data.
4. Compile case-level and summary surveillance data each year and
submit these data to CDC in a timely (see Definitions:Timeliness)
manner for use in a multi-State TBI surveillance data base. Case level
data must be formatted according the CDC Guidelines for Surveillance of
Central Nervous System Injury.
5. Develop a yearly work plan which includes measurable objectives
with appropriate time lines and associated activities.
B. CDC Activities:
1. Provide technical assistance for effective surveillance program
planning and management.
2. Provide technical assistance to evaluate the surveillance system
for completeness and validity.
3. Maintain and analyze multi-State data and regularly report
analysis findings.
4. Conduct site visits to assess program progress and mutually
resolve problems, as needed.
5. Facilitate communication/coordination among States to improve
efficiency of activities and quality of surveillance data.

Part II

Recipients of funds for Part II are expected to develop or
enhance--and evaluate--a population-based registry to collect follow-up
data on persons hospitalized with TBI Statewide or in a population
defined by a geopolitical jurisdiction of the State of 1.5 million or
more. It is expected that recipients of these funds will build on the
experience gained and methods developed by the project funded in 1995
under Announcement 526--Part II (Colorado). It is also expected
recipients of these funds will collaborate with one another in order to
develop their projects.
A. Recipient Activities include but are not limited to:
1. Define the target population.
2. Develop tracking mechanisms to facilitate follow up of persons
with TBI; i.e., develop and maintain access to persons who have been
hospitalized for TBI.
3. Define the minimal data set for follow-up, and interview and/or
other methods of follow-up and data collection. The data set should
include information about primary and secondary conditions, injury
severity, motor and sensory impairments, disability, handicap,
recommended use and actual use of post-acute care services (so cost
estimates can be generated), community integration, and demographic
information.
4. Collect follow up data from a representative sample of the
population of persons sustaining TBI. It is expected that a sample
representing persons with mild, moderate, and severe TBI can be
developed to adequately define the parameters in item three, above.
5. Analyze follow-up data.
6. Evaluate the usefulness of hospital emergency department data
for TBI in a variety of hospital settings (e.g., urban public
hospitals, rural hospitals, level I, II, and III trauma centers, large
community hospitals, etc.). It is expected that ED records from a
variety of hospital settings will be selected in order to evaluate the
accuracy--including sensitivity and predictive value positive--of ED
data for TBI surveillance. Applicants are not expected to define the
incidence of TBI treated in the ED, but are expected to evaluate the
quality, and therefore the usefulness, of ED data for TBI surveillance.
7. In collaboration with the other funded project, convene two
meetings of experts to address outcomes associated with TBI treated in
EDs but not hospitalized. These meetings should address relevant public
health outcome measures and methods to collect these data.
8. Produce yearly reports of analyses and of project progress;
document the costs of maintaining the registry.
9. Evaluate project progress, and evaluate the completeness and
accuracy of the data.
10. Develop a yearly work plan that includes measurable objectives
with appropriate time lines and associated activities.
11. Collaborate with the other recipient of Part II funding.
12. Share project case level and summary data with CDC.
B. CDC Activities:
1. Provide ongoing consultation with funded recipients in areas
outlined under Part II, Activities A.2., A.3., A.4., A.6., A.7., and
A.9., above.
2. Provide technical assistance in establishing or endorsing
criteria for completeness, timeliness, and accuracy of data, and
monitor to ensure compliance with program (recipient) activities.
3. Analyze and provide technical assistance for analysis of TBI
follow-up data, for the evaluation of ED data for TBI surveillance, and
for convening meetings of experts to address outcomes associated with
non-hospitalized TBI.
4. Conduct site visits to assess program progress and mutually
resolve problems, as needed.
5. Facilitate the IRB review process at CDC.
6. Facilitate coordination between recipients of Part II funds.

Technical Reporting Requirements

An original and two copies of semi-annual progress reports are
required of all grantees. Time lines for the semi-annual reports will
be established at the time of award. Final financial status and
performance reports are required no later than 90 days after the end of
the project period. All reports are submitted to the Grants Management
Branch, CDC.
Semiannual progress reports should include:
A. A brief program description.

[[Page 10389]]

B. A Statement of the goals and objectives, followed by comparisons
with the actual accomplishments for the period.
C. If established goals and objectives were not accomplished or
were delayed, describe both the reason for the deviation and
anticipated corrective action or deletion of the activity from the
project.
D. Other pertinent information, including the status of
completeness, timeliness and quality of data, published reports from
surveillance efforts, as well as other materials published by the
project.

Application Content

A separate application must be submitted for each part (Part I and/
or Part II) of this announcement for which funding is requested.
Applicants are required to submit an original and two copies of their
application. The application, including appendices, should not exceed
55 pages for Part I and 65 pages for Part II.
Competing continuation applicants (Parts I & II) may include up to
five additional pages to describe outcomes from the previously funded
program.
The first page of the application should contain the response to
requirements as indicated in the Application Requirements section of
this announcement.
Pages should be clearly numbered and a complete index to the
application and any appendices included. The project narrative section
must be double-spaced. The original and each copy of the application
must be submitted unstapled and unbound. All materials must be
typewritten, double-spaced where noted, with unreduced type (font size
10 point or greater) on 8-1/2'' by 11'' paper, with at least 1''
margins, headers and footers, and printed on one side only.
The applicant should provide a detailed description of first-year
activities and briefly describe future-year objectives and activities.
For TBI surveillance applications (Part I), the application must
include:
A. Application Requirements Declaration (see Application
Requirements).
B. Executive Summary (one page, may be single spaced): This section
should include:
1. Type of federal assistance requested: Part I, support of an
existing population-based TBI surveillance system.
2. Existing resources for the program.
3. Major objectives and components for the proposed program.
4. The amount of federal assistance requested.
C. Proposal Narrative (not to exceed 25 double-spaced pages
excluding the budget narrative and appendices, 30 double-spaced pages
for competing continuations): This section should include:
1. A brief description of the need for TBI surveillance within the
jurisdiction applying for assistance.
2. A description of the existing TBI surveillance program within
the jurisdiction, including the following:
a. Existing staff and brief summary of their qualifications.
b. A description of the applicant's capacity for data entry, data
processing, and data analysis.
c. Methods of case ascertainment and data collection, including:
(1) Case definition.
(2) Data elements collected.
(3) Sources of data used to ascertain cases.
(4) Other sources of data used to provide additional information on
cases.
d. Legal authority to conduct surveillance (e.g., TBI reporting
legislation or regulation), and legal authority and methods to ensure
data confidentiality.
e. A brief summary of any data analyses completed.
f. A brief summary of any evaluations of surveillance data quality
or timeliness.
g. A progress narrative (not to exceed five pages) documenting
project outcomes (competing continuations only).
3. A description of goals and specific, measurable, and time-linked
objectives for the proposed surveillance program. A schedule of
attainment should be included.
4. A description of methods to achieve the proposed surveillance
program objectives. This must include at least the following:
a. Proposed methods of case ascertainment and data collection,
including:
(1) The TBI case definition and its consistency with the CDC case
definition.
(2) A listing of data elements proposed to be collected. This
should include (but need not be limited to) data elements contained in
the standard variables of the CDC Guidelines for Central Nervous System
Injury Surveillance. At a minimum, data elements collected for every
case should include birth date, age, sex, county (or zip code) of
residence, ICD-9 or ICD-9-CM diagnostic codes, dates of hospital
admission and discharge (if applicable) or dates of injury and death
(if applicable), and type of hospital discharge disposition (if
applicable). It is also expected that in at least a representative
sample of reported cases, additional data elements will be collected
describing injury cause (using either E-codes or CDC etiology codes),
severity, and outcome, as described in the CDC Guidelines. Data formats
must be consistent with the CDC Guidelines.
(3) All sources of data that would be used to ascertain cases. At a
minimum this should include vital records (death certificates) and
hospital discharge data. Hospital discharge data may be obtained from
Statewide hospital discharge data sets, or may be obtained directly
from all individual hospitals within the jurisdiction that provide
acute care for head injuries.
(4) All other sources of data that are used to provide additional
information on cases. At a minimum this should include hospital medical
records, which may be reviewed in a representative sample of cases.
(5) A detailed description of the population sampling methods used
to obtain additional case information from medical records and other
data sources (see previous section). This is important to validate case
reports and collect additional data concerning injury risk factors,
causes, severity, and outcome. Because of the time required to abstract
such records and the large number of reported cases, it is not expected
that all reported cases be abstracted. Sampling methods should ensure
representativeness of the sample, but may involve more intensive
sampling of some strata with fewer reported cases (e.g., moderate and
severe cases). The qualifications of data abstractors and quality
control of this data collection should also be addressed.
b. Evidence of legal authority to conduct all aspects of
surveillance, including authority that gives the applicant access to
and authority to collect all necessary vital records data, hospital
discharge data, and medical records within the jurisdiction and protect
the confidentiality of this data. A letter from the official State
public health agency or other State agency or department, or from the
State Attorney General's Office assuring that appropriate State
authorities exist should be provided, which cites relevant language
from State laws and/or regulations. Appropriate State authorities at a
minimum must provide proof of the ability to collect and protect the
confidentiality of essential data from State death certificates,
hospital discharge data, and hospital medical records for all cases of
traumatic brain injury occurring in the State.

[[Page 10390]]

c. A description of the applicant's capability for the entry,
management, processing and analysis of data, including a description of
computer hardware and software resources; a description of methods and
time line to ensure timely delivery of edited case-level data to CDC.
d. Appropriate letters of commitment, such as letters from agencies
that will provide the project with essential data or access to data.
5. A description of plans to evaluate the attainment of proposed
objectives, including plans to evaluate the sensitivity and predictive
value positive of case ascertainment and the completeness and quality
of data.
6. A description of the schedule by which annual case-level data
will be submitted to the CDC.
7. A brief description of the proposed use of data for injury
prevention programs.
8. A detailed first-year budget and narrative justification with
future annual projections. Budgets should include costs for travel for
two project staff to attend one meeting in Atlanta with CDC staff.
9. Human Subjects: Indicate whether human subjects will be
involved, and if so, how will they be protected, and describe the
review process which will govern their participation (see also Other
Requirements Section, Human Subjects).
For Population-Based Registries applications (Part II)--The
application must include:
A. Application Requirements Declaration (see Application
Requirements).
B. Executive Summary (one page, may be single spaced): This section
should include:
1. Type of federal assistance requested: Part II, development of a
TBI follow-up registry based on an existing population-based
surveillance program.
2. Existing resources for the program.
3. Major objectives and components for the proposed program.
4. The amount of federal assistance requested.
C. Proposal Narrative (not to exceed 35 double-spaced pages
excluding the budget narrative and appendices, 40 double-spaced pages
for a competing continuation project). This Section should include:
1. A description of the need for a TBI registry and the objectives
for the registry. Describe the purpose of the TBI registry data
including:
a. A description of how the data will contribute to the applicant's
public health mission and fit with other activities in the
organization.
b. A description of how the data will contribute to current TBI
prevention and service activities as well as a description of potential
intervention activities.
2. A description of existing TBI surveillance capacity, including a
summary of current surveillance data (i.e., 1995 or 1996).
3. A characterization of the target population including: a. A
description of the target population under surveillance, including how
it constitutes a discrete geopolitical jurisdiction; and the size and
demographic features such as age, sex, and race/ethnicity.
Demonstration of population characteristics that may reflect the
disability status of the population, such as employment status,
educational attainment, and income, is desirable. This includes the
extent to which the applicant has met the CDC Policy requirements
regarding the inclusion of women, ethnic, and racial groups in the
proposed project, including:
(1) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation; (2) The
proposed justification when representation is limited or absent; (3) A
statement as to whether the design of the study is adequate to measure
differences when warranted; and (4) A statement as to whether the plans
for recruitment and outreach for study participants include the process
of establishing partnerships with community(ies) and recognition of
mutual benefits.
4. A description of the applicant's ability to track persons who
have sustained TBI and collect health data. High follow-up rates are
vital to the success of a registry. Describe the attributes enhancing
and impeding follow-up of incident TBI cases, including: a. The
applicant's legislative or regulatory authority to collect and maintain
health data with identifying information for members of the target
population who have had a TBI. This description should include the
language currently in place which supports the legal authority of the
health department to develop or enhance a central TBI registry.
b. Prior experience conducting follow-up studies or running other
registries that would be pertinent to the applicant's capacity to
develop or enhance a TBI registry. A discussion of the relevance of
these prior endeavors to proposed efforts should be included.
c. Plans to locate registry participants, anticipated barriers to
follow-up, and plans to address the barriers.
d. Legal authority and methods to maintain data confidentiality.
5. A description of the applicant's methodologic capacity--
specifically, management capacity for planning and maintaining the
registry, and scientific resources for data management and analysis of
data collected through the TBI registry, including:
a. Organization chart(s) to establish relationships between the
registry and support resources.
b. Experience with data management, analysis and use of registry-
type (for example, follow-up) data.
c. If appropriate, describe plans for and evidence of collaborative
relationships with agencies (including universities and non-
governmental entities) that will provide needed expertise.
6. A description of planned data collection. For a newly funded
project, sufficient time in the first budget year should be devoted to
planning, establishing infrastructure, and developing data collection
instruments in collaboration with CDC and the other recipient of Part
II funds. Familiarity should be demonstrated with data needs and data
collection issues of a TBI registry, including:
a. A demonstration of familiarity with concepts of impairment,
disability, handicap, and secondary conditions.
b. A description of potentially useful public health outcome
measures of disability, including relevant published data collection
instruments.
c. A description of methods to be employed at follow up that will
assess disability and handicap, and a description of methods to be
employed to assess pre-TBI baseline function.
d. A description of other existing computerized health data systems
that might be useful for the ongoing monitoring of registry
participants, and a description of the applicant's authority and
experience in linking such data systems.
e. A description of existing computer hardware and software
resources and anticipated needs to maintain the registry, including for
the purposes of data linkage, analysis and transmission to the CDC.
7. Describe the overall operational plan for development,
implementation, and ongoing management of the TBI registry including:
a. A realistic time line with measurable milestones.
b. A management and staffing plan describing qualifications and
experience of existing and proposed staff, and responsibilities of each
position.
c. The methods for registry participant enrollment, for data
collection (e.g.,

[[Page 10391]]

telephone versus in-person interview, record abstraction), and for
confidentiality. A description of the TBI severity and care spectrum of
registry participants to be enrolled and followed should be included.
d. A description of analysis plans for data collected through the
registry.
e. If applicable, plans for and evidence of collaborative
relationships with agencies (including universities and non-
governmental entities) relevant to the surveillance of TBI and the
monitoring of the health, service needs, and community integration of
injured persons.
f. If the applicant has an established follow-up registry for TBI,
a description of how methods will be shared and how technical support
may be given to the other recipient of Part II funding.
g. Plans to share project case level and summary data with the CDC.
8. A description of methods to evaluate the usefulness of hospital
emergency department data for surveillance of non-hospitalized TBI.
This must include the following:
a. Proposed methods of case ascertainment, including case
definition(s), data collected, and sources of data within the hospital
to identify cases and to provide additional information about the TBI
(e.g., administrative and clinical emergency department data sources,
radiology reports, emergency medical service data).
b. A description of how ED cases will be selected, including a
description of which hospitals will participate (or will be selected to
participate), the characteristics of those hospitals, the proposed
number of cases needed from each hospital, and the rationale for how
cases will be identified.
c. A description of methods to evaluate sensitivity, predictive
value positive and the quality of data collected in the ED.
9. In collaboration with CDC and the other funded project, an
agreement to convene two meetings of experts to address outcomes
associated with TBI treated in emergency departments but not
hospitalized. These meetings should address relevant public health
outcome measures for TBIs treated in emergency departments and
methodologies to collect data among this group.
10. A description of plans to evaluate the attainment of proposed
objectives, including (where applicable) plans to evaluate the quality
of the registry and ED data collected (e.g., completeness and
validity).
11. As applicable, a progress narrative (not to exceed five double-
spaced pages) to address progress and outcomes from the prior-funded
project.
12. Human Subjects: Indicate how human subjects will be protected,
and describe the review process which will govern their participation
(see Other Requirements Section, Human Subjects).

Evaluation Criteria

Upon receipt, applications for Part I and Part II will be reviewed
by CDC staff for completeness and affirmative responses as outlined
under the previous heading, Application Requirements. Incomplete
applications and applications which are not responsive will be returned
to the applicant without further consideration.
An objective review of the applications which are successful in the
preliminary review will then be conducted according to the following
criteria:

Part I--Evaluation Criteria

Evaluation criteria are based on the responsiveness to and quality
of specific information requested in section Application Content.
1. Needs Assessment (5 points). The extent to which the applicant
describes the impact of TBI in the applicant's jurisdiction and the
need for TBI data for public health programs.
2. Existing Surveillance Program and Resources (40 points total).
The status of the applicant's existing TBI surveillance program, and
the degree to which it currently serves the requirements and purposes
of this cooperative agreement. Priority will be given to:
a. programs including in this application a summary of current
(i.e., 1995 or 1996) TBI morbidity and mortality data analyzed by age,
sex, and cause, [5 points];
b. programs that have evaluated the quality of their data (e.g.,
predictive value positive, completeness, timeliness), [5 points];
c. programs that have abstracted records of a population-based
sample to characterize the external cause, severity, and outcome of TBI
(e.g., by abstracting data from medical records in a representative
sample of reported cases), [10 points];
d. programs providing a progress report that details participation
in CDC's multi-State TBI surveillance system, addressing progress and
outcomes from the previous three-year funding period, [20 points].
3. Goals and Objectives (10 points). The extent to which objectives
are specific, achievable, practical, measurable, time-linked, and
consistent with the overall purposes described in this announcement.
4. Methods and Activities (20 points). The application will be
scored according to the extent that the proposed methods and activities
can achieve the proposed objectives, consistent with the purposes of
this announcement. The extent to which clear explanations of
appropriate methods addressing case ascertainment and data collection,
TBI case definition(s), data elements, sources and availability of
data, sampling methods, legal authority for surveillance activities,
protection of confidentiality, and data processing and analysis are
provided. The applicant should also describe methods for sharing
project data with the CDC.
5. Staffing and Management (15 points). The extent to which
proposed staffing, organizational structure, staff qualifications and
experience, identified training needs or plan, and job descriptions and
curricula vitae for both proposed and current staff indicate the
applicant's ability to carry out the objectives of the program.
6. Evaluation (10 points). The degree to which the applicant
includes plans to evaluate the attainment of proposed objectives,
including plans to evaluate the sensitivity and predictive value
positive of case ascertainment and the completeness and quality of
data.
7. Budget (not scored). The extent to which the budget is
reasonable, clearly justified, and consistent with stated objectives
and proposed activities.
8. Human Subjects Review (not scored). The applicant must clearly
state what precautions exist to protect human subjects.

Part II--Evaluation Criteria

Evaluation criteria are based on the responsiveness to, and quality
of, specific information requested in this section. See also
Application Content Section in this announcement.
1. Statement of Need for TBI Follow-up Data, and Registry Goals and
Objectives: (5 points). The extent to which the applicant describes
plans for using a TBI registry that respond to public health needs and
are linked with prevention and service activities; the extent to which
the project goals and objectives are specific, achievable, measurable,
time-linked, and consistent with the overall purposes described in this
announcement.
2. Existing TBI Surveillance Capacity: (10 points). The extent to
which the applicant describes an effective incidence surveillance
system for TBI and addresses the following issues: The objectives for
incidence surveillance,

[[Page 10392]]

the case definitions for TBI, the sources of TBI case reporting, the
timeliness of case ascertainment, the completeness of case
ascertainment and other qualitative attributes of the system, a summary
of current surveillance data (i.e., 1995 or 1996), and a description of
the prior usefulness of the system.
3. Definition and Scope of the Target Population: (10 points). The
extent to which a discrete, geopolitical jurisdiction can be
established and the following issues are addressed: Demonstrated access
to descriptive data concerning the target population, including
measures relevant to the disability status of the target population,
and a thorough justification and description of sampling or restricting
the target population for participation in the registry. Breadth of
socio-demographic representation in the target population and relevance
to the national population will be scored favorably.
This includes the extent to which the applicant has met the CDC
Policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed project including: (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; and (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.
4. Ability to Track TBI Patients and Collect Health Data: (15
points). While authority to collect and maintain personal identifiers
from TBI incidence surveillance is a requirement for Part II
eligibility, the ability to track participants and collect follow-up
information is so important to the success of the registry that scoring
will reflect the extent to which the applicant demonstrates legislative
and/or regulatory authority to conduct a TBI registry, shows prior
successful experience following a population and collecting health
information at prospective intervals, understands the barriers to
locating registry participants for follow-up data collection and
presents appropriate plans to overcome those barriers, and demonstrates
proper authority and methods to maintain confidentiality of health
information with personal identifiers.
5. Methodologic Capacity, Project Management and Staffing: (15
points). The extent to which the scientific resources for planning and
data management/analysis of a TBI registry are demonstrated within the
applicant's organization or through collaboration with universities or
other agencies. The extent to which proposed staffing, staff
qualifications and experience, and project organization indicates
ability to accomplish the objectives of the program.
6. Data Collection: (15 points). For a newly funded project,
planning, establishing infrastructure, and developing data collection
instruments are expected to occur during the first year. Under these
circumstances the application will be scored according to the extent to
which familiarity with data needs and data collection issues is
demonstrated in the proposal, including the concepts of impairment,
disability, handicap, and secondary conditions. Awareness of published
data collection instruments used to measure outcome measures of
disability and handicap and assess health status prior to injury should
be demonstrated, as well as awareness of the technical resources
necessary to conduct the registry.
Applicants with established TBI registry projects should describe
experience with--and proposed changes involving--data collection
instruments and methods.
All applicants should describe implemented or proposed methods to
conduct follow-up interviews and link pertinent health data systems to
enhance data collection.
7. Operational Plan: (10 points). The extent to which the registry
methods and timetable are realistic, milestones are measurable, and
proposed products are commensurate with the size of the cooperative
agreement award. The spectrum of TBI severity addressed within the
registry should be as broad as possible, and the data collection
methods should be appropriate for the type of data proposed for
collection.
8. Evaluation of Hospital Emergency Department Data for TBI
Surveillance and Developing Outcome Measures for Non-hospitalized TBI:
(10 points). The extent to which the applicant's proposed methods and
activities will evaluate the quality of hospital ED data relevant to
TBI surveillance. The extent to which clear explanations of
appropriate, achievable methods are presented demonstrating access to
hospital ED data, demonstrating access to other data sources within the
hospital, and to evaluate sensitivity, predictive value positive, and
the quality of ED data for TBI surveillance. In addition, the extent to
which the applicant demonstrates a willingness to collaborate with CDC
and the other funded project to address outcomes issues among persons
treated in EDs for TBI.
9. Evaluation Plan: (10 points). The degree to which the applicant
includes plans to evaluate the attainment of proposed objectives,
including plans to evaluate the quality of the data collected through
the registry.
10. Budget (not scored). The extent to which the budget is
reasonable, clearly justified, and consistent with stated objectives
and proposed activities described in this announcement.
11. Human Subjects (not scored). The applicant must clearly state
what precautions are in place to protect human subjects. Activities
under Part II of this announcement are subject to an IRB review at CDC.
An IRB must also review this project at the State level. The State
review should occur after the project has been reviewed at CDC (see
also Human Subjects).
Funding Preferences: During the selection process CDC will attempt
to ensure a balanced geographic distribution of funded TBI surveillance
and registry projects.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants should contact their State Single
Point of Contact (SPOC) as early as possible to alert them to the
prospective applications and receive any necessary instructions on the
State process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of SPOCs is included in the application kit. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should send them to Ron Van Duyne, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Mailstop E-13, Atlanta, GA 30305. The receipt date for SPOC comments
will be 60 days after publication in the Federal Register. The Program
Announcement Number and Program Title should be referenced on the
document. The granting agency does not guarantee to ``accommodate or
explain'' the State process recommendations it receives after that
date.

[[Page 10393]]

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting
Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.136.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more
individuals and funded by the cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.

Human Subjects

If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations, 45 CFR part 46, regarding the protection of human subjects
(see Application Contents, parts I and II). Assurance must be provided
to demonstrate that the project will be subject to initial and
continuing review by an appropriate institutional review committee. The
applicant will be responsible for providing assurance in accordance
with the appropriate guidelines and form(s) provided in the application
kit. Applicants under Part II of this announcement are subject to an
IRB review at CDC. The CDC IRB review should occur before an IRB
reviews the project at the State level. Additional information and
forms will be available as part of the application package mentioned
under Where to Obtain Additional Information Section.

Women and Racial and Ethnic Minorities

It is the policy of the CDC to ensure that women and racial and
ethnic groups will be included in CDC-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian or Alaska Native, Asian, Black or African American,
Native Hawaiian or Other Pacific Islander, and Hispanic or Latino.
Applicants shall ensure that women and racial and ethnic minority
populations are appropriately represented in applications for research
involving human subjects. Where clear and compelling rationale exist
that inclusion is not feasible, this situation must be explained as
part of the application. In conducting the review of applications for
scientific merit, review groups will evaluate proposed plans for
inclusion of minorities and both sexes as part of the scientific
assessment and assigned score. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity and/or
sex of subjects. Further guidance to this policy is contained in the
Federal Register, Vol. 60, No. 179, Friday, September 15, 1995, pages
47947-47951.

Application Submission and Deadline

The original and two copies of the application PHS Form 5161-1 (OMB
Number 0937-0189) must be submitted to Joanne Wojcik, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 300, Mailstop E-13, Atlanta, GA 30305, on or before May
7, 1998.
1. Deadline: Applications shall be considered as meeting the
deadline if they are either;
a. Received on or before the deadline date; or
b. Sent on or before the deadline date and received in time for
submission to the objective review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks will not be acceptable as proof of timely mailing.)
2. Late Applications: Applications that do not meet the criteria in
1.a. or 1.b. above are considered late applications. Late applications
will not be considered in the current competition and will be returned
to the applicant.

Where to Obtain Additional Information

To receive additional written information call 1-888-GRANTS4 (1-
888-472-6874). You will be asked your name and address and will need to
refer to Announcement 98022. You will receive a complete program
description, information on application procedures, and application
forms. In addition, this announcement is also available through the CDC
Home Page on the Internet. The address for the CDC Home Page is (http:/
/www.cdc.gov).
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Joanne Wojcik, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-13,
Atlanta, GA 30305, telephone (404) 842-6535, or Internet address
[email protected].
Programmatic technical assistance, including additional information
developed by the existing registry project, may be obtained from Joseph
Sniezek, M.D., Division of Acute Care, Rehabilitation Research and
Disability Prevention, National Center for Injury Prevention and
Control, Centers for Disease Control and Prevention (CDC), 4770 Buford
Highway, NE., Mailstop F-41, Atlanta, GA 30341-3724, telephone (404)
488-4244 or Internet address [email protected].
Please refer to Announcement 98022 when requesting information and
submitting an application.
Potential applicants may obtain a copy of ``Healthy People 2000''
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''
(Summary Report, Stock No. 017-001-00473-1) referenced in the
Introduction Section through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325, telephone (202)
512-1800.

Dated: February 25, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).

TRAUMATIC BRAIN INJURY SURVEILLANCE REFERENCES

Methods and Key Resources

Thurman DJ, Sniezek JE, Johnson D, Greenspan A, Smith SM. Guidelines
for Surveillance of Central Nervous System Injury. Atlanta: Centers
for Disease Control and Prevention, 1995.
Klaucke DN, Buehler JW, Thacker SB, et al. Guidelines for evaluating
surveillance systems. MMWR 1988;37(s-5):1-18.
Health Care Financing Administration. International Classification
of Diseases, 9th Revision, Clinical Modification, Third Edition.
Washington, DC: U.S. Department of Health and Human Services, 1989.
Brooks CA, Gabella B, Hoffman R, Sosin D, Whiteneck G. Traumatic
brain injury: designing and implementing a population-based follow-
up system. Arch Phys Med Rehabil 1997; 78:S26-S30.

Epidemiologic Studies and Reviews

Centers for Disease Control and Prevention. Traumatic Brain Injury--
Colorado, Missouri, Oklahoma, and Utah, 1990-93. MMWR 1997; 46(1):8-
11.
Kraus JF, McArthur DL. Epidemiologic aspects of brain injury.
Neurologic Clinics 1996; 14(2):435-50.
Sosin DM, Sniezek JE, Waxweiler RJ. Trends in death associated with
traumatic brain injury, 1979 through 1992. JAMA 1995; 273:1778.

[[Page 10394]]

Published epidemiologic studies of TBI are also reviewed in the
article ``Epidemiology of Traumatic Brain Injury in the United
States'' located at the Internet website of the National Center for
Injury Prevention and Control http://www.cdc.gov/ncipc/dacrrdp/
tbi.htm>.
How to Obtain a Copy of the CDC Guidelines for Surveillance of
Central Nervous System Injury:
A copy of these Guidelines can be obtained either by calling
770-488-4031, by submitting the ``NCIPC Publications Order Form''
through the Internet website of the National Center for Injury
Prevention and Control http://www.cdc.gov/ncipc/pub-res/
pubsav.htm>, or by writing to the Division of Acute Care,
Rehabilitation Research, and Disability Prevention, National Center
for Injury Prevention and Control, Centers for Disease Control and
Prevention (CDC), 4770 Buford Highway, NE., Mailstop F-41, Atlanta,
GA 30341-3724.

[FR Doc. 98-5389 Filed 3-2-98; 8:45 am]
BILLING CODE 4163-18-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-5389. Public record. Not legal advice.