[Federal Register Volume 63, Number 41 (Tuesday, March 3, 1998)]
[Notices]
[Pages 10385-10394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 98022]


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

Introduction

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

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

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

Authority

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

Smoke-Free Workplace

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

Eligible Applicants

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

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

[[Page 10386]]

Availability of Funds

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

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

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

Use of Funds

Restriction on Lobbying

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

Prohibition on Use of CDC Funds for Certain Gun Control Activities

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

Background & Definitions

Background

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

[[Page 10387]]

medical, rehabilitation, and social services. In fact, most of what is 
known about outcomes is based on studies that rely on case series 
methodology, small regional samples, and anecdotal reports. Greater 
understanding of these issues is important for several reasons: First, 
a better understanding of outcomes will add to our knowledge about the 
public health impact and societal costs associated with disabling 
injuries. Second, a better understanding of specific impairments 
associated with disabling injuries could lead to improving acute care 
and rehabilitation interventions aimed at reducing the severity of 
impairment and related disabilities. Third, little is known about 
barriers to receiving needed rehabilitation and other health-related 
services following TBI. In 1995, under Announcement 526--Part II, CDC 
funded one State (Colorado) to develop a population-based registry of 
persons with TBI to assess the outcomes they experience and their need 
for services in the year following injury.
    Additionally, there is a critical lack of information about 
outcomes experienced by persons who experience a TBI which does not 
result in hospitalization. Critical work is needed to evaluate the 
quality of emergency department data for TBI surveillance, to define 
relevant public health outcome measures for persons with TBI who are 
not hospitalized, and to develop methods to collect outcome data among 
this group.

Definitions

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

Purpose

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

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

Application Requirements

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

[[Page 10388]]

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

Cooperative Activities

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

Part I

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

Part II

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

Technical Reporting Requirements

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

[[Page 10389]]

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

Application Content

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

[[Page 10390]]

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

[[Page 10391]]

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

Evaluation Criteria

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

Part I--Evaluation Criteria

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

Part II--Evaluation Criteria

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

[[Page 10392]]

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

Executive Order 12372 Review

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

[[Page 10393]]

Public Health System Reporting Requirements

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

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.136.

Other Requirements

Paperwork Reduction Act

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

Human Subjects

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

Women and Racial and Ethnic Minorities

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

Application Submission and Deadline

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

Where to Obtain Additional Information

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

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

TRAUMATIC BRAIN INJURY SURVEILLANCE REFERENCES

Methods and Key Resources

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

Epidemiologic Studies and Reviews

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


[[Page 10394]]


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

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