[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Notices]
[Pages 6540-6546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 716]


Traumatic Brain Injury Surveillance Program Notice of 
Availability of Funds for Fiscal Year 1997

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds for a cooperative agreement 
program for population-based data systems for Traumatic Brain Injury 
(TBI). The intent of the program is to further develop a multi-state, 
population-based surveillance system for TBI that began in FY 1995. The 
development of population-based surveillance for TBI fulfills, in part, 
activities mandated in Public Law 104-166, The Traumatic Brain Injury 
Act, enacted in 1996. This program will serve two purposes:
    Part I--To enhance existing State or territory surveillance systems 
for TBI, to ensure they are population-based and provide high quality, 
useful data.
    Part II--To develop TBI surveillance systems in States or 
territories that have not received past funding from CDC for this 
purpose and have legal authority to collect TBI data but have little or 
no surveillance infrastructure. 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 Injury, 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, and 392, 
of the Public Health Service Act (42 U.S.C. 241, 247b, 280b, and 280b-
1) as amended, including Pub. L. 104-166.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Pub. L. 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 State public health agencies 
or other State agencies or departments. 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 agency.
    Only one application from each State may enter the review process 
and be considered for an award under this program. Applicants may apply 
for either Part I or Part II funding as most appropriate, but not both.
    For Part I, applicants who are funded under Announcement 526 are 
not eligible for this program.
    For Part II, applicants who have received past funding for TBI 
Surveillance from CDC (from the National Center for Injury Prevention 
and Control (NCIPC) or the National Center for Environmental Health 
(NCEH)) are not eligible for this program.

Availability of Funds

    Approximately $1,550,000 is available in FY 1997 to fund up to 
eleven awards under Parts I and II of this announcement:
    Part I--Approximately $1,200,000 is available in FY 1997 to fund 
six to eight awards to enhance existing State surveillance systems for 
TBI. It is expected that the average award will be $150,000, ranging 
from $125,000 to $175,000.
    Part II--Approximately $350,000 is available in FY 1997 to fund two 
to three awards to assist in planning TBI surveillance systems. It is 
expected that the average award will be $115,000, ranging from $90,000 
to $125,000.
    Projects are expected to begin on or about August 1, 1997, and will 
be made for a 12-month budget period within a project period of up to 3 
years. Funding estimates may vary and are subject to change.
    Funds may be used for personnel services, supplies, equipment, 
travel, subcontracts, and services directly related to project 
activities. Project funds cannot be used to supplant other existing 
funds for surveillance or registry activities, for construction costs, 
or to lease or purchase facilities or space.

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    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.
    Funding Preferences: During the selection process CDC will make 
every effort to ensure a balanced geographic distribution.

Use of Funds

    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, 1997 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 1997 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 and 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 indicate that these injuries are important public 
health problems. TBI is also preventable.
     Some estimates and studies of incidence have indicated 
that traumatic brain injuries may result in 260,000 hospitalizations 
and 52,000 deaths each year.
     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.
     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.
     Injuries are largely preventable. The leading causes of 
TBI are motor-vehicle crashes, falls, and violence.
    Despite the magnitude of the problem of TBI, surveillance systems 
in only a few U.S. jurisdictions are adequately monitoring its impact. 
In the past, most of the data on TBIs have been collected in: (1) 
Hospital-based clinical case series, (2) epidemiological studies 
restricted to particular times and locales, (3) registries maintained 
by government agencies responsible for providing services for persons 
with these injuries, and (4) state-based public health surveillance 
systems for TBI.
    Hospital-based clinical case series. Data collected at hospitals 
treating persons with Central Nervous System (CNS) injuries have been 
used mainly to assess clinical course, treatment efficacy and quality 
of care. Usually these data are not collected from all the hospitals 
serving a geographic area; instead these data include only persons who 
present at a particular hospital or group of hospitals for treatment. 
Thus, the data may be unrepresentative of injury occurrence in the 
entire population of the geographic area. They provide no information 
on persons in the area who fail to receive treatment at the hospitals 
collecting the data, persons whose characteristics may differ 
substantially from those who do receive treatment at these hospitals.
    Epidemiological Studies. Although epidemiological studies designed 
to estimate the incidence of TBI have been useful, published studies 
have been limited to certain geographic areas and to earlier time 
periods. These studies, although valuable in defining the size of the 
problem and describing etiologies of injury, have not been ongoing. 
Therefore, they have not provided sufficient data to define patterns in 
TBI over time, to assess changes in such patterns, and to evaluate the 
effectiveness of current prevention programs. Furthermore, in 
specialized studies, investigators have used varying definitions of TBI 
and inclusion criteria, making comparison across studies (and therefore 
across jurisdictions) difficult. Studies of these injuries have 
produced a broad range of incidence estimates.
    Service-based registries. Until recently, TBI case reports were 
often collected in registries developed to plan and provide for patient 
and family services. These were often collected by agencies of State 
government not involved in traditional public health prevention 
activities (e.g., mental health, vocational rehabilitation, and other 
rehabilitation services). Because of the service delivery focus of 
registries, little information was collected on the etiologies of 
injuries, limiting the usefulness of these data for prevention program 
planning. These data are seldom used for public health program 
planning.
    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--some efforts growing out of previous 
registry efforts. These data systems are just beginning to provide 
ongoing population-based incidence and etiologic information that is 
useful to plan and evaluate public health programs. Building on these 
efforts, in 1995, CDC funded four States to conduct ongoing population-
based surveillance for TBI. Methods of data collection vary among these 
surveillance systems, some employing legal reporting requirements for 
CNS injuries similar to reporting requirements for certain communicable 
diseases, some using existing hospital discharge data systems or trauma 
registries, and some relying on a combination of these methods.

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

[[Page 6542]]

jurisdictions, these data are only separately maintained by each 
hospital.

Purpose

    The purpose of this program is to improve the quality and 
availability of TBI data:
    Part I--To enhance existing TBI surveillance systems in order to 
develop a multi-state surveillance system which will use common case 
definitions and data base. This surveillance system will better define 
the magnitude of TBI at a national level, define the spectrum of 
severity of injury, better define populations at high risk, and define 
the distribution of external causes of injury in order to plan injury 
control programs addressing prevention and service provision. CDC's 
Guidelines for Central Nervous System Injury Surveillance will be the 
standards used.
    Part II--To develop new TBI surveillance systems in States or 
territories with authority to collect TBI data but which have had no 
prior funding from CDC to develop TBI surveillance and which have 
little or no TBI surveillance infrastructure. These State-based 
surveillance systems will also become part of the multi-state 
surveillance system described under Part I by the end of the project 
period. CDC's Guidelines for Central Nervous System Injury Surveillance 
will be the standards used.

Program Requirements

    Part I--The applicant must:
    1. Demonstrate the existence of a statewide (or territory-wide) 
population-based TBI surveillance system or a population-based TBI 
surveillance system in a geo-political jurisdiction of 1.5 million 
people or more.
    2. Document that legislation and/or regulations are in place which 
support current collection of TBI data, and protect the confidentiality 
of this data.
    3. Demonstrate the availability of at least one year of TBI data 
from the TBI surveillance system (from calendar year 1993, 1994, or 
1995).
    Part II--The applicant must: Document that legislation and/or 
regulations are in place which support current collection of TBI data, 
and protect the confidentiality of this data.
    Both Part I and Part II applicants are to provide a 1 page Summary 
which includes:
    1. Type of Federal assistance requested: Part I or Part II.
    2. A succinct, but informative, response to each application 
program requirement.
    An affirmative response to each requirement is required to qualify 
for the full objective review. This page should be included as the 
first page of the application and titled ``Program Requirements.''

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).

Part I

    Recipients of awards under Part I of this announcement will develop 
an enhanced statewide (or territory-wide) population-based TBI 
surveillance or population-based TBI surveillance within a geo-
political jurisdiction of 1.5 million or more.
    A. Recipient Activities include but will not be limited to:
    1. Conduct surveillance for TBI using the definitions and variables 
as defined in the CDC Guidelines for Central Nervous System Injury 
Surveillance. Recipients will collect information addressing 
demographics, etiology, severity and outcome.
    2. Access and use mortality data and hospital patient data, using 
vital records (death certificates and/or multiple-cause-of-death data) 
and linking them to hospital discharge data to produce a non-
duplicative data base for the population under surveillance.
    3. Evaluate the surveillance system for completeness and validity 
of data collected using methods described in ``Guidelines for 
Evaluating Surveillance Systems.''
    4. Develop and submit an annual report of the analysis of 
surveillance data.
    5. Compile and submit timely case-level surveillance data yearly 
(in each budget period) to CDC for use in a multi-state TBI 
surveillance data base formatted per CDC Guidelines for Central Nervous 
System Injury Surveillance.
    6. 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 and for application of the CDC Guidelines for 
Central Nervous System Injury Surveillance.
    2. Provide technical assistance to evaluate the surveillance system 
for completeness and validity.
    3. Maintain multi-state data base to develop TBI rates and other 
information for reports and other publications, when appropriate. 
Standard practices for co-authorship and publication among CDC and 
participating recipients will be followed according to the Manual 
Guide--General Administration No. CDC-69, Authorship of CDC or ATSDR 
Publications (12/1/95).

Part II

    Recipients of awards under Part II of this announcement will 
develop statewide (or territory-wide) population-based TBI surveillance 
or population-based TBI surveillance within a geo-political 
jurisdiction of 1.5 million or more.
    A. Recipient Activities include but are not limited to:
    1. Develop and implement a 3-year plan to conduct TBI surveillance 
using the CDC Guidelines for Central Nervous System Injury 
Surveillance. Recipients will be expected to collect information 
addressing demographics, etiology, severity and outcome.
    2. Use mortality data and hospital patient data, using vital 
records (death certificates and/or multiple-cause-of-death data) and 
linking them to hospital discharge data to produce a non-duplicative 
data base for the population under surveillance.
    3. Develop and submit an annual report on progress of the 
developing TBI surveillance system.
    4. Compile and submit case-level surveillance data to CDC in a 
timely manner for use in a multi-state TBI surveillance data base 
formatted per CDC Guidelines for Central Nervous System Injury 
Surveillance.
    5. Where applicable, evaluate the surveillance system for 
completeness and validity of data collected using methods described in 
``Guidelines for Evaluating Surveillance Systems.''
    6. 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 and for application of the CDC Guidelines for 
Central Nervous System Injury Surveillance.
    2. Provide technical assistance for data management and analysis.
    3. Maintain multi-state data base to develop TBI rates and other 
information for reports and other publications, when appropriate. 
Standard practices for co-authorship and publication among CDC and 
participating recipients will be followed according to the Manual 
Guide--General Administration No. CDC-69, Authorship of CDC or ATSDR 
Publications (12/1/95).

[[Page 6543]]

Technical Reporting Requirements

    An original and two copies of semi-annual progress reports are 
required of all awardees. 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, Procurement and Grants Office, CDC.
    Semi-annual progress reports should include:
    A. A brief program description.
    B. A listing of program goals and objectives, accompanied by a 
comparison of the actual accomplishments related to the goals and 
objectives established 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 annual reports 
from surveillance efforts, as well as other materials published related 
to the surveillance system.
    For Part II, any other information about the progress of 
surveillance system development should be included.

Application Content

    The entire application, including appendices, should not exceed 60 
pages and the Proposal Narrative section contained therein should not 
exceed 25 pages. The first page of the application should contain the 
response to the Program Requirements section and be marked ``Program 
Requirements.'' 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, 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.

Part I--Application Content

    A. Provide a 1 page Abstract which includes:
    1. Existing resources for the program.
    2. Major objectives and components for the proposed program.
    B. Proposal Narrative (not to exceed 25 double-space pages 
excluding the budget narrative and appendices): This section should 
include:
    1. A brief description of the needs 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. 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.
    c. A brief summary of any data analyses completed.
    d. A brief summary of any evaluations of surveillance data quality 
or timeliness.
    3. A description of goals and specific, measurable, and time-linked 
objectives for the proposed surveillance program. Any proposed 
enhancements of the program should be noted. 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 staff and qualifications. If staff are to be hired, 
assurances from the agency that position(s) are available and can be 
filled in a timely manner must be included.
    b. 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 core variables of the CDC Guidelines for Central Nervous System 
Injury Surveillance. Data element formats must be consistent with the 
CDC Guidelines. 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. Other data elements may be collected 
electively (e.g., medical service charges).
    (3) All sources of data that would be used to ascertain cases. At a 
minimum this should include vital records (death certificates and/or 
multiple-cause-of-death data) and hospital discharge data. Hospital 
discharge data may be obtained from state-wide hospital discharge data 
systems, or may be obtained directly from all individual hospitals 
within the jurisdiction that provide acute care for brain injuries.
    (4) All other sources of data that would be 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. Other, optional sources of data might include, for 
example, police reports or medical examiner records.
    (5) A brief description of the sampling strategy proposed 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 strategies 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 be addressed.
    c. 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 
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.
    d. A description of the applicant's capability for the entry, 
management,

[[Page 6544]]

processing and analysis of data, including a description of computer 
hardware and software resources; a description of methods and timeline 
to ensure timely delivery of edited case-level data to CDC.
    e. Appropriate letters of commitment, such as letters from agencies 
that will provide the project with essential data or access to data.
    f. A brief description of the proposed use of data for injury 
prevention programs.
    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 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.

Part II--Application Content

    A. Provide a 1 page Abstract which includes:
    1. Existing resources for the program.
    2. Major objectives and components for the proposed program.
    B. Proposal Narrative (not to exceed 25 double-space pages 
excluding the budget narrative and appendices). This Section should 
include:
    1. A brief description of the needs for TBI surveillance within the 
jurisdiction applying for assistance.
    2. A description of the existing TBI surveillance resources within 
the jurisdiction, including the following:
    a. Existing staff and brief summary of their qualifications.
    b. Available TBI data, including:
    (1) Case definition (s).
    (2) Data elements collected.
    (3) Sources of data used to ascertain cases.
    c. A brief summary of any available analyses of TBI data.
    3. A description of goals and specific, measurable, and time-linked 
objectives for the development of TBI surveillance. A schedule of 
attainment should be included.
    4. A description of planned activities to address the objectives to 
develop TBI surveillance. This must include at least the following:
    a. Proposed staff and qualifications. If staff are to be hired, 
assurances from the agency that position(s) are available and can be 
filled in a timely manner must be included.
    b. Proposed methods of case ascertainment and data collection, 
including:
    (1) The TBI case definition, consistent 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 core variables of the CDC Guidelines for Central Nervous System 
Injury Surveillance. When data are submitted to CDC, they must be in a 
format consistent with the CDC Guidelines.
    (a) 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 expected that 
population-based data including these variables, obtained by linking 
hospital discharge data with vital records data, will be compiled and 
submitted in a timely manner, but no later than the end of the project 
period.
    (b) It is also expected that in at least a representative sample of 
reported cases, including morbidity and mortality, 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.
    (3) All sources of data that would be used to ascertain cases. At a 
minimum this should include vital records (death certificates or 
multiple-cause-of-death data) and hospital discharge data. Hospital 
discharge data may be obtained from state-wide hospital discharge data 
systems, 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 would be 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. Other, optional sources of data might include police 
reports or medical examiner records.
    (5) A brief description of plans to develop a sampling strategy to 
obtain additional case information from medical records and other data 
sources (see previous section).
    c. 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 
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.
    d. A description of the applicant's plans to develop capability for 
the entry, management, processing and analysis of data, including a 
description of computer hardware and software resources; a description 
of methods and timeline to ensure timely delivery of edited case-level 
data to CDC.
    e. Appropriate letters of commitment, such as letters from agencies 
that will provide the project with essential data or access to data.
    f. A description of the proposed use of data for injury prevention 
programs.
    5. A description of plans for a process evaluation of the 
attainment of proposed objectives.
    6. 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.

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, ``PROGRAM REQUIREMENTS.'' Incomplete 
applications and applications that are not responsive will be returned 
to the applicant without further consideration.
    An Objective Review of applications that are successful in the 
preliminary review will then be conducted according to the following 
criteria:

Part I--Evaluation Criteria

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 (25 points)

    The current status of the applicant's existing TBI surveillance 
program, and the degree to which it can be adapted to serve the 
requirements and purposes of this cooperative agreement. Important 
issues include access to critical data sources (vital records, hospital 
discharge data, and medical records); established relationships between 
the applicant and data providers (including

[[Page 6545]]

letters of support); legal authority to obtain and protect the 
confidentiality of data; currentness of existing TBI morbidity and 
mortality data analyzed by age, sex, and cause; ability 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); and established relationships with TBI advocacy and prevention 
organizations and programs.

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 (30 points)

    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 and to 
protect confidentiality, and data processing and analysis are provided.

5. Project Management and Staffing (20 points)

    The extent to which proposed staffing, organizational structure, 
staff experience and background, identified training needs or plan, and 
job descriptions and curricula vitae for both proposed and current 
staff indicate ability to carry out the objectives of the program. 
Assurances that proposed positions are available and can be filled in a 
timely manner.

6. Evaluation (10 points)

    The degree to which the applicant includes adequate 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.

Part II--Evaluation Criteria

1. Needs Assessment (10 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 Resources (20 points)

    The potential of the applicant's existing TBI surveillance 
activities and resources to serve the requirements and purposes of this 
cooperative agreement. Critical issues include availability of and 
access to critical data sources (vital records, hospital discharge 
data, and medical records), and legal authority to obtain and protect 
the confidentiality of data.

3. Goals and Objectives (15 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 (30 points)

    The extent that the proposed plans and activities can achieve the 
proposed objectives for surveillance, 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 
(including letters of support), legal authority for surveillance 
activities and to protect confidentiality, and data processing and 
analysis are provided.

5. Project Management and Staffing (15 points)

    The extent to which proposed staffing, organizational structure, 
staff experience and background, identified training needs or plan, and 
job descriptions and curricula vitae for both proposed and current 
staff indicate ability to carry out the objectives of the program. 
Proposed staffing should include epidemiologic and data management 
capacity. Assurances that proposed positions are available and can be 
filled in a timely manner.

6. Evaluation (10 points)

    The degree to which the applicant includes adequate plans for a 
process evaluation of the attainment of proposed objectives.

7. Budget (not scored)

    The extent to which the budget is reasonable, clearly justified, 
and consistent with stated objectives and proposed activities.

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 S. 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., 
Room 300, Mailstop E-13, Atlanta, GA 30305, no later than 60 days after 
the application deadline. 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.

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.

Application Submission and Deadline

    The original and two copies of the application PHS Form 5161-1 
(Revised 7/92, OMB Number 0937-0189) must be submitted to Joanne A. 
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 April 16, 1997.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either;
    a. Received on or before the deadline date; or

[[Page 6546]]

    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 (404) 332-4561. You 
will be asked to leave your name, address, and telephone number and 
will need to reference to Announcement 716. You will receive a complete 
program description, information on application procedures, and 
applications forms.
    If you have questions after reviewing the contents of all the 
documents, business management 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 may be obtained from David J. 
Thurman, M.D., M.P.H., 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 (770) 
488-4031 or internet address <[email protected]>.
    This and other CDC announcements are available through the CDC 
homepage on the Internet. The address for the CDC homepage is <http://
www.cdc.gov>.
    CDC will not send application kits by facsimile or express mail.
    Please refer to Announcement 716 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'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: February 6, 1997.
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.

Epidemiologic Studies and Reviews

Kraus, JF. Epidemiology of head injury. In Cooper, PR, ed., Head 
Injury, Third Edition. Baltimore: Williams and Wilkins, 1993; 1-25.
Sosin DM, Sniezek JE, Waxweiler RJ. Trends in death associated with 
traumatic brain injury, 1979 through 1992. JAMA 1995; 273:1778.

    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>.

Centers for Disease Control and Prevention. Traumatic Brain Injury--
Colorado, Missouri, Oklahoma, and Utah, 1990-93. MMWR 1997; 46(1):8-11.

    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. 97-3473 Filed 2-11-97; 8:45 am]
BILLING CODE 4163-18-P