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

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