Part B for0920-0004

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 – Arboviral Surveillance (ArboNET)

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS     

1. Respondent Universe and Sampling Methods

ArboNET is a passive electronic surveillance system administered by CDC’s Division of Vector-Borne Diseases in Fort Collins, Colorado. Respondents include 50 state and 3 local or territorial health departments (New York City, District of Columbia, and Puerto Rico) that report to ArboNET. Human disease cases due to West Nile virus, California serogroup viruses, St. Louis, Eastern and Western encephalitis viruses, and Powassan virus are nationally notifiable; other arboviral infections can be reported to ArboNET on a voluntary basis. No sample selection is involved in this surveillance activity.

2. Procedures for Collection of Information

ArboNET involves 100% electronic reporting of national arbovirus surveillance data, with no paper forms. Fax and phone are secondary collection methods occasionally used in urgent situations. Jurisdictions transmit data to ArboNET using one or more of three standardized methods developed and supported by the Division of Vector-Borne Diseases. Jurisdictions that already have an electronic surveillance system can upload multiple records from their system using an Extensible Markup Language (XML) message; jurisdictions without an electronic surveillance system can upload multiple records from a Microsoft Access database using an XML message; or any jurisdiction may enter records manually using a Web-based form.

3. Methods to Maximize Response Rates and Deal with Non-response

ArboNET is a passive surveillance system. As such, no specific measures are taken to maximize response rates and/or deal with non-response.

4. Test of Procedures or Methods to be Undertaken

This is a revision of previously approved data collection. Only minor changes to the electronic database have been made to collect enhanced surveillance data to identify risk factors for hospitalization and death among persons with WNV disease. These findings could be used to target WNV prevention efforts or focus future WNV immunization strategies. Participation in this enhanced surveillance is voluntary because not all states routinely collect these data. A voluntary system allows states collecting data a mechanism to report them while not requiring states that have not been routinely collecting such data to report.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Data reported to ArboNET are received and analyzed by the Arboviral Disease Branch of the Division of Vector-Borne Diseases in Fort Collins, Colorado. Division statisticians are available for support as needed.

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 – Campylobacter, Cholera and other vibrio illness, Foodborne Outbreaks,

Shigella, Salmonella, and Listeria

1. Respondent Universe and Sampling Methods

No sample selection is involved in this surveillance study.  The surveillance report forms and instructions are distributed to all States and Territories of the United States.  State and local health department staff submits these reports to CDC on variable frequencies ---- weekly, monthly, or quarterly. In certain circumstances, such as outbreak situations, reports are first made by telephone, and then followed by a written report. CDC then calculates and publishes weekly statistics via the Morbidity and Mortality Weekly Report (MMWR), providing the states with timely aggregates of their submissions.

2. Procedures for Collection of Information

Data on disease and preventable conditions are collected in accordance with jointly approved plans by CDC and the Council of State and Territorial Epidemiologist (CSTE).  Changes in the surveillance program and in reporting methods are affected in the same manner.  At the beginning of this surveillance program CSTE and CDC decided which diseases warranted surveillance.  These diseases are reviewed and revised based on variations in the public’s health. 

3. Methods to Maximize Response Rates and Deal with Non-response

      There is not a method to deal with non-response as the state public health laboratories submit the disease surveillance forms as a part of their job to perform a public health service. 

4. Test of Procedures or Methods to be Undertaken

      This is a revision of a previously approved data collection, only minor changes to the data collection instruments have been made.  No other test of procedures has been performed. 

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

The Biostatistics and Information Management Branch, Division of Foodborne, Waterborne, and Environmental Diseases. 

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 Calicivirus

1. Respondent Universe and Sampling Methods – CaliciNet is a national network of public health laboratories that contribute to a database of genetic sequences from noroviruses identified in outbreaks. As more states participate, CaliciNet may find links to help identify multistate outbreaks, detect potential norovirus-contaminated food before preparation and serving, and identify the emergence of new norovirus strains.  This network compares norovirus sequences to be able to rapidly link norovirus outbreaks with a common food source as well as to identify emerging norovirus strains. CaliciNet went live in March 2009 and currently has 24 states certified for participation.

2. Procedures for Collection of Information – Certified participants gain access to CaliciNet via a two-part process: 1. CDC access via a secure CDC website using an assigned key fob and 2. Server access with an assigned user login and password. Participants upload on a monthly basis (biweekly during September – May). Electronic uploading allows immediate processing and analysis of national trends and allows for data correction by participating centers. The data collected in this surveillance system contain unique specimen identifiers that allow for tracking at the outbreak level, not specimen level.  No person identifiable data are collected. The respondents submit molecular results and genotype data on specimens positive for norovirus.  Once entry is complete, the data are stored on a secure SQL server, accessible only by the CaliciNet information Technology staff and the database adminstrator.

3. Methods to Maximize Response Rates and Deal with Non-response –  There are currently 24 laboratories participating in CaliciNet. CaliciNet is a passive surveillance system and participation is voluntary.  Approximately 30% of laboratories report in a timely manner every two weeks during the high norovirus season, based on which genotype trends can be estimated.  The remaining 70% labs report the information late, and this information is incorporated into later summaries of the data. CaliciNet actively encourages participating laboratories to increase uploads during the norovirus season, but norovirus season also coincides with influenza season testing of which has priority over norovirus in most of the participating laboratories.

4. Test of Procedures or Methods to be Undertaken   -     Participating laboratories report nucleic acid detection and genotyping results for norovirus. 

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data - The following individuals are involved in analysis and management of the data:

CaliciNet Administrator:  experienced, bachelor-level microbiologist, manages data, performs quality assurance, analyzes on weekly basis

CaliciNet Team Lead: available for consultation on more complex analysis of data

State Public Health Laboratories: manages data entry

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 – Enterovirus

1. Respondent Universe and Sampling Methods – The National Enterovirus Surveillance System (NESS) is a laboratory-based system that monitors temporal and geographic patterns in the occurrence of enteroviruses and human parechoviruses. Data are collected from state public health laboratories and commercial laboratories.

2. Procedures for Collection of Information- In order to submit reports to NESS, each laboratory is required to have a digital certificate that is registered under the Secure Digital Network, SDN. Laboratories are encouraged to report enterovirus detections by serotype, specimen type, collection date, age of patient, and sex of patient to CDC monthly. Electronic reporting allows immediate processing and analysis of national trends and allows for data correction by participating laboratories. The data collected are of individual form, but no identifiers or distinguishable personal-level data are included in this surveillance system. Once entry is complete, the data are housed on a secure SQL server, accessible only by the Office of Informatics technical developer and the NESS coordinator.

3. Methods to Maximize Response Rates and Deal with Non-response –  There are currently approximately 10-20 labs participating in NESS. NESS is a passive surveillance system and participation is voluntary. Participating laboratories are encouraged to report enterovirus and parechoviruses detections to CDC monthly. Most laboratories do not respond on a monthly basis but more on a quarterly basis since there are only a few detections to report each month, if any. NESS could be improved with more regular reporting by current laboratories and by increasing the number of participating laboratories. Non-response is not a significant issue with NESS; however, summary reports are usually published every two years giving laboratories enough time to submit data.

4. Test of Procedures or Methods to be Undertaken - Laboratories are encouraged to report enterovirus detections by serotype and specimen type.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data - The following individuals are involved in analysis and management of the data:

NESS coordinator:  masters-level epidemiologist, manages data, analyzes on weekly basis

Backup coordinator:  experienced, masters-level epidemiologist who assists with coordination

Branch statistical team: masters- or doctoral-level statisticians available for consultation on more complex analysis of data

Agency informatics staff:  manage data entry and storage system

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 Harmful Algal Bloom-related Illness (HABISS)

The HABISS coordinator will conduct periodic statistical analyses on the data in the system. Statistical analyses will be done using SAS (SAS Institute, Cary, NC) and Microsoft Access. Quarterly summary statistics will include:

• Number of possible, probable, and confirmed human cases per state

• Mean age of case

• Numeric distribution of signs/symptoms

• Numeric distribution of mechanism of exposure

• Temporal trends / standard epidemiologic curves

• Geographic trends

• Other descriptive statistics

The HABISS coordinator may employ the following methodology:

• Data transformation

• Case classification

• Baseline estimation

• Underlying pattern detection

1. Respondent Universe and Sampling Methods

This activity is not research; respondents are neither recruited nor sampled. Furthermore, no sample selection is involved in this surveillance study. The surveillance instructions will be distributed to the states that are awarded funding for HABISS data entry. State and local department staff submits these reports to NCEH on monthly basis.

2. Procedures for the Collection of Information

Data on disease and preventable conditions are collected in accordance with jointly approved plans by CDC and the Council of State and Territorial Epidemiologist (CSTE). Changes in the surveillance program and in reporting methods are affected in the same manner. At the beginning of this surveillance program CSTE and CDC decided which diseases warranted surveillance. These diseases are reviewed and revised based on variations in the public’s health.

3. Methods to Maximize Response Rates and Deal with Non-response

There is not a method to deal with non-response since the state entities will submit surveillance data as part of their HABISS grant activity. Therefore, the response rate is expected to be close to 100%.

4. Tests of Procedures or Methods to be Undertaken

A beta version of HABISS was carried out in Florida and North Carolina. No further procedures or methods are needed at this time.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Individuals consulted on statistical aspects:

Dana Flanders, PhD

Health Statistician

National Center for Environmental Health

Centers for Disease Control and Prevention

Chamblee, GA 30341

E: flanders@sph.emory.edu

P: 770-488-3472

Stephanie Kieszak, MPH

Health Statistician

National Center for Environmental Health

Centers for Disease Control and Prevention

Chamblee, GA 30341

E: skieszak@cdc.gov

P: 770-488-3407

Person responsible for oversight, data collection, and analysis:

Lorraine C. Backer, PhD, MPH

Division of Environmental Health Hazards and Evaluation

National Center for Environmental Health

Centers for Disease Control and Prevention

4770 Buford Highway, MS F-57

Atlanta, GA 30341

E: LBacker@cdc.gov

P: 770-488-3426

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 -- Influenza

1. Respondent Universe and Sampling Methods

The influenza surveillance forms and instructions are distributed to all states and territories in the United States. States and select local health department staff, volunteer healthcare providers, laboratories, vital statistics registrars, and other appropriate public health partners submit these reports to CDC on a weekly basis. Statistical calculations are made on all influenza surveillance data collected through the U.S. influenza surveillance system.  Data is published in a weekly influenza surveillance report (FluView) from October to May, in periodic Morbidity and Mortality Weekly Report (MMWR) influenza activity summaries, and peer-reviewed articles.

2. Procedures for Collection of Information

The Influenza Division at CDC collects, compiles and analyzes information on influenza activity year round in the United States and produces FluView, a weekly influenza surveillance report, from October through mid-May. The U.S. influenza surveillance system is a collaborative effort between CDC and its many partners in state, local, and territorial health departments, public health and clinical laboratories, vital statistics offices, healthcare providers, clinics, and emergency departments. Any modifications to surveillance systems or reporting methods are done in collaboration with the Council of State and Territorial Epidemiologists (CSTE).

3. Methods to Maximize Response Rates and Deal with Non-response

Reporting of weekly surveillance reports is done on a voluntary basis. Many partners in state, local, and territorial health departments, volunteer healthcare providers, laboratories, vital statistics registrars, and other appropriate public health partners submit surveillance forms as part of their job to perform a public health service. If follow up is necessary, an Influenza Division staff member will contact the appropriate public health partner.

4. Test of Procedures or Methods to be Undertaken

This is a revision of a previously approved data collection. Due to the 2009 influenza A (H1N1) pandemic, daily reporting forms and additional surveillance forms were created for data collection and will be used in the event of another pandemic or public health emergency. No other test of procedures has been performed.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

It is the responsibility of the Influenza Division/Epidemiology and Prevention Branch staff to compile, manage, and analyze data collected through the U.S. influenza surveillance system.

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 -- Rabies

1. Respondent Universe and Sampling Methods

• Monthly Report of Laboratory Confirmed Cases of Rabies: CDC 55.28

  • State or Territorial Health Departments not providing enhanced animal rabies surveillance

• Enhanced Animal Rabies Surveillance (electronic)

  • State and Territorial Health Departments

• Possible Human Rabies Patient Information (paper)

  • Hospitals submitting samples for human rabies diagnostic testing

2. Procedures for Collection of Information

The rabies program at CDC collects, compiles and analyzes information on rabies activity year round in the United States and produces annual surveillance reports. The U.S. rabies surveillance system is a collaborative effort between CDC and its many partners in state, local, and territorial health departments; public health, state agricultural, and university laboratories; as well as U.S. Department of Agriculture / Wildlife Services. Any modifications to surveillance systems or reporting methods are done in collaboration with the Council of State and Territorial Epidemiologists (CSTE).

Information is collected from different data sources that allow CDC to find out when and where rabies activity is occurring, track rabies circulation in wildlife animal reservoirs, determine what rabies virus variants are circulating, detect changes in rabies viruses, and monitor for the introduction of non-enzootic rabies virus variants. These data sources are described below.

• Monthly Report of Laboratory Confirmed Cases of Rabies: CDC 55.28

  • For the reporting of animal rabies, most respondents have converted from the hard-copy aggregate reporting form to electronic reporting of enhanced animal rabies surveillance data. Aggregate case reporting continues to be used by a few respondents that have not yet moved to electronic reporting. Aggregate numbers of laboratory confirmed rabid animals by species and county are submitted monthly on a paper form.

• Enhanced Animal Rabies Surveillance (electronic)

  • Enhanced animal rabies surveillance consists of additional information on all animals tested for rabies by state public health, state agricultural, and university laboratories. Enhanced information includes individual demographics on each animal submitted for rabies testing such as: human and animal exposures, animal rabies vaccination status, detailed animal collection locations, and rabies virus variant information. The Rabies Surveillance Network involves 100% electronic reporting of national animal rabies data, with no forms. Requested data elements and structure for reporting are specified and data is provided in various formats (either completely automated through PHLIS-PHINMS or periodic email submission of data exported from pre-established state surveillance databases). Frequency of enhanced rabies testing data is variable ranging from weekly to monthly depending on submission rates of animals for rabies testing at state laboratories. Animal rabies data is routinely available ad hoc for participating state and federal partners via the Rabies Surveillance Network web-based application in addition to an annual summary available publicly in the Journal of the American Veterinary Medicine Association.

• Possible Human Rabies Patient Information (paper)

  • The Possible Human Rabies Patient Information form, a standardized questionnaire which contains detailed questions on relevant clinical and epidemiologic features of possible human rabies cases, was developed by CDC to collect important information on potential human rabies cases that submit samples to the CDC rabies laboratory for diagnostic testing. This information is submitted ad hoc by physicians when submitting samples for rabies diagnosis accounting for approximately 50 submissions each year. Because of the relatively rare occurrence of human rabies these cases are presented on an individual basis as case reports in MMWR. Reviews of overall trends in human rabies cases are tabulated and published on a semi-decadal basis.

3. Methods to Maximize Response Rates and Deal with Non-response

• Animal Surveillance

  • Data collected through the U.S. animal rabies surveillance system answers the questions of where, when, and what rabies viruses are circulating in domestic and wild animal reservoirs. It can be used to determine if rabies activity is increasing or decreasing in animal populations, but cannot be used to definitively ascertain prevalence of rabies in wildlife animal populations. Many partners in state, local, and territorial health departments, laboratories, and other appropriate public health partners submit surveillance forms on a monthly basis as part of their job to perform a public health service. If follow up is necessary, a rabies team staff member will send emails and/or make phone calls to the appropriate public health partner. We believe that participants in the U.S. rabies surveillance system will have significant interest in contributing towards national efforts to monitor rabies activity. We have historically received a high degree of participation and anticipate this to continue.

• Possible Human Rabies Patient

  • Data collected on possible human rabies patients is provided as part of the requirements for processing diagnostic samples submitted to the CDC rabies section laboratory. This form includes relevant contact information from submitting physicians to evaluate patients for possible rabies infection and provide timely diagnostic results back to the submitter. In the event of incomplete submission of information a rabies team staff member will contact the attending physician to clarify as required. As this form is incorporated into providing a diagnostic service to physicians we expect a high degree of participation.

4. Test of Procedures or Methods to be Undertaken

This is a revision of a previously approved data collection. Forms have been updated to reflect enhanced data collection and submission methods by state and territorial partners. No other test of procedures has been performed. OMB will be informed of changes to the survey procedures or data collection instruments.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Jesse Blanton

Epidemiologist, Rabies Team

Poxvirus and Rabies Branch

Division of High-Consequence Pathogens and Pathology

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd, NE

Atlanta, GA 30333

(404) 639-2289

JBlanton@cdc.gov

Charles Rupprecht

Chief, Rabies Team

Poxvirus and Rabies Branch

Division of High-Consequence Pathogens and Pathology

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd, NE

Atlanta, GA 30333

(404) 639-2289

JBlanton@cdc.gov

Data will be collected by state and select local health departments, laboratories, healthcare providers, and other appropriate public health partners, as described previously. It is the responsibility of the rabies program staff to compile, manage, and analyze data collected through the U.S. rabies surveillance system.

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 -- Respiratory and Enteric

1. Respondent Universe and Sampling Methods –

The National Respiratory and Enteric Virus Surveillance System (NREVSS) is a laboratory-based system that monitors temporal and geographic patterns in the occurrence of several respiratory and enteric viruses, including respiratory syncytial virus (RSV), human parainfluenza viruses (HPIV), respiratory and enteric adenoviruses and rotavirus. Data are collected from collaborating university and community hospital laboratories, selected state and county public health laboratories, and commercial laboratories. These participating laboratories report virus antigen detections, isolations and electron microscopy results on a weekly basis. 

2. Procedures for Collection of Information

Reporting is conducted weekly using a secure CDC website.   Electronic reporting allows immediate processing and analysis of national trends and allows for data correction by participating centers.   The weekly reports collected via NREVSS are analyzed by CDC staff and the results are immediately updated on a public CDC website.  The data collected are in aggregate form and no identifiers are included in this surveillance system.  The respondents only submit the total number of tests performed for each virus and the total number of positive results.  No person-level data is collected.  Once entry is complete, the data are housed on a secure SQL server, accessible only by the Office of Informatics technical developer and the NREVSS coordinator.  Graphs are updated weekly on the CDC’s public website for NREVSS.  In addition, MMWR reports of viral activity are published each year for RSV, and occasionally for other viruses included in the surveillance system.  Reports are also periodically published in peer-reviewed journals.   

3. Methods to Maximize Response Rates and Deal with Non-response

There are currently approximately 300 labs participating in NREVSS, though not all laboratories submit results for all the listed pathogens.  NREVSS is a passive surveillance system and participation is voluntary.  Nonetheless, approximately 85% of laboratories report in a timely manner each week during the high respiratory season, which allows an accurate determination of trends.  In addition, many of the 15% of the other labs report the information late, and this information is incorporated in later summaries of the data.  So non-response is not a significant issue with NREVSS.

4. Test of Procedures or Methods to be Undertaken 

Participating laboratories report virus antigen detections, nucleic acid detections, viral isolations and electron microscopy results for the pathogens under surveillance.  These results are reported in aggregate (i.e., the number of tests performed and the number of tests positive in the prior week).

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data: 

The following individuals are involved in analysis and management of the data:

NREVSS coordinator:  masters-level epidemiologist, manages data, analyzes on weekly basis

Backup coordinator:  experienced, masters-level epidemiologist who assists with coordination

Branch statistical team: available for consultation on more complex analysis of data

Agency informatics staff:  manage data entry and storage system

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 -- Waterborne Disease Outbreaks

1. Respondent Universe and Sampling Methods

No sample selection is involved in waterborne disease outbreak reporting. The surveillance report forms and instructions are distributed to all States and Territories of the United States. State and territorial health department staff submits these reports to CDC on variable frequencies ---- weekly, monthly, or quarterly. For some waterborne disease outbreaks, reports are first made by telephone, and then followed by a written report. CDC calculates and publishes biennial surveillance summaries via the Morbidity and Mortality Weekly Report (MMWR), providing the states with aggregates of their submissions.

2. Procedures for Collection of Information

Data on waterborne disease outbreaks are collected in accordance with jointly approved plans by CDC and the Council of State and Territorial Epidemiologist (CSTE). Changes in the surveillance program and in reporting methods are affected in the same manner. Beginning in 2009, waterborne disease outbreaks are reported to CDC through the National Outbreak Reporting System (NORS). Primary contacts for CDC are at the state and territory level. At the request of current state or territorial contacts, CDC may also contact local public health staff regarding data collection.

3. Methods to Maximize Response Rates and Deal with Non-response

There is not a method to deal with non-response as state and territorial public health departments submit waterborne disease outbreak reports as a part of their job to perform a public health service.

4. Test of Procedures or Methods to be Undertaken

No test of procedures has been performed.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

The Biostatistics and Information Management Branch, Division of Foodborne, Waterborne, and Environmental Diseases, CDC.

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004-- Babesiosis

1. Respondent Universe and Sampling Methods

The babesiosis case report form will be distributed to all interested state and territorial health departments in the United States. Routine surveillance of select nationally notifiable conditions (including babesiosis) is conducted by state and territorial health departments, and case reports are submitted weekly to CDC. This passive national surveillance system does not involve sampling.

2. Procedures for Collection of Information

State and territorial health departments collect case-level data in accordance with their regulations. Reporting of weekly surveillance reports is voluntary. States submit cases to CDC using the Nationally Notifiable Diseases Surveillance System, which contains the National Electronic Diseases Surveillance System (NEDSS, OMB 0920-0728), an internet-based infrastructure for public health surveillance data exchange that uses specific Public Health Information Network (PHIN). NEDSS electronic data and information standards advance the development of efficient, integrated, and interoperable surveillance systems at federal, state and local levels. Babesiosis-specific data elements included on the case report form will be integrated into the electronic reporting mechanisms. Any modifications to surveillance systems or reporting methods are done in collaboration with the Council of State and Territorial Epidemiologists (CSTE).

3. Methods to Maximize Response Rates and Deal with Non-response

Case notification messaging encourages the use of electronic reporting to improve response and completeness. General data elements and babesiosis-specific elements will be included in a Health Level 7 v2.5 (HL7) message format Message Mapping Guide (MMG), developed by the NEDSS and NNDSS programs, in collaboration with state and federal subject matter experts, to implement case notification to CDC via NEDSS. If follow up is necessary, a Parasitic Diseases Branch staff member will contact the appropriate public health partner. There are no methods in place to deal with non-response at the federal level.

4. Test of Procedures or Methods to be Undertaken

The national babesiosis case report form is based on case report forms that have been used by state health departments for a number of years, and the data being collected represent standard clinical and demographic information. No other test of procedures has been performed.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

CDC's Public Health Surveillance Program Office is responsible for establishing and managing the national reporting system of epidemiologic data for notifiable conditions. Basic descriptive analyses of case-level surveillance and babesiosis-specific data will be conducted by Division of Parasitic Diseases and Malaria/Parasitic Diseases Branch staff.

NATIONAL DISEASE SURVEILLANCE PROGRAM - II.

DISEASE SUMMARIES

OMB 0920-0004 -- Brucellosis

1. Respondent Universe and Sampling Methods

No sample selection is involved in national brucellosis surveillance. CDC conducts population-based passive surveillance for nationally notifiable conditions, which includes brucellosis, and includes all cases in the defined catchment area (i.e., all recognized states and territories of the Union). Therefore, the data collection covers the entire United States population.

2. Procedures for Collection of Information

Brucellosis case finding is passive and either laboratory or epidemiologically-based. The case definition requires definitive laboratory evidence to confirm a case, while presumptive laboratory evidence or epidemiological linkages are required to classify a case as probable. Case notifications are to be sent to CDC under the auspices of a nationally notifiable condition by state and territorial public health departments. Any modifications to surveillance of nationally notifiable conditions and reporting methods are done in collaboration with the Council of State and Territorial Epidemiologists (CSTE).

State and territorial public health departments typically investigate brucellosis cases due to the rarity of the disease and the bioterrorism potential of the etiologic agent. Many health departments use the CDC brucellosis case report form (CRF) last published in 1980 to record their investigative findings in lieu of developing their own form. The case data are then entered into an electronic system; core demographic variables are regularly transmitted to CDC.

3. Methods to Maximize Response Rates and Deal with Non-response

Reporting of weekly surveillance reports is done on a voluntary basis. Many partners in state, local, and territorial health departments, volunteer healthcare providers, laboratories, vital statistics registrars, and other appropriate public health partners submit surveillance forms as part of their job to perform a public health service. If follow up is necessary, a Bacterial Special Pathogens Branch staff member will contact the appropriate public health partner.

4. Test of Procedures or Methods to be Undertaken

The data being collected represents standard clinical and demographic information. No tests of procedures or questions were preformed.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Individuals collecting data are state or territorial health department employees, who follow their agency-specific guidelines for collection of case-surveillance data. It is the responsibility of the Bacterial Special Pathogens Branch staff, with assistance from the Division of High-Consequence Pathogens and Pathology statistics group, to manage and analyze data collected through national brucellosis surveillance.