97-3473. Traumatic Brain Injury Surveillance Program Notice of Availability of Funds for Fiscal Year 1997  

  • [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
    
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    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).
    
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    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,
    
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    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 jcw6@cdc.gov>.
        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 dxt9@cdc.gov>.
        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
    
    
    

Document Information

Published:
02/12/1997
Department:
Centers for Disease Control and Prevention
Entry Type:
Notice
Document Number:
97-3473
Pages:
6540-6546 (7 pages)
Docket Numbers:
Announcement 716
PDF File:
97-3473.pdf