National Notifiable Diseases Surveillance System
Supporting Statement Section A
OMB Control Number 0920-0728
April 23, 2020
Program Contact
Umed A. Ajani
Associate Director for Science, Division of Health Informatics and Surveillance
Center for Surveillance, Epidemiology and Laboratory Services
Centers for Disease Control and Prevention
Phone: 404-498-0258
E-mail: [email protected]
National Notifiable Diseases Surveillance System - Request for Revision
Table of Contents
Section
A. Justification
Circumstances Making the Collection of Information Necessary
Purpose and Use of the Information Collection
Use of Improved Information Technology and Burden Reduction
Efforts to Identify Duplication and Use of Similar Information
Impact on Small Businesses or Other Small Entities
Consequences of Collecting the Information Less frequently
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
Explanation of Any Payment or Gift to Respondents
Protection of the Privacy and Confidentiality of Information Provided by Respondents
Institutional Review Board (IRB) and Justification for Sensitive Questions
Estimates of Annualized Burden Hours and Costs
Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
Annualized Cost to the Federal Government
Explanation for Program Changes or Adjustments
Plans for Tabulation and Publication and Project Time Schedule
Reason(s) Display of OMB Expiration Date is Inappropriate
Exceptions to Certification for Paperwork Reduction Act Submissions
Exhibits
Exhibit 12-A Estimates of Annualized Burden Hours
Exhibit 12-B Estimates of Annualized Burden Costs
Exhibit 14-A Estimated Annualized Cost to the Government
Attachments
1. Authorizing Legislation
2a. 60-day Federal Register Notice (FRN)
3. List of Nationally Notifiable Conditions
4. List of Conditions Under Standardized Surveillance
5. Core Data
6. Laboratory Data
7. Vaccine Data
8. Vaccine Preventable Disease Data
9. Justification for the Addition of Disease-Specific Data Elements
10. Disease-Specific Data
11. Consultants List
12. DW PIA
13. DMB PIA
14. MVPS PIA
15. NNDSS Research Determination
16. Burden Table Calculations
17. PRA Burden Statement Screenshot
A. Justification
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A1. Circumstances Making the Collection of Information Necessary
CDC requests a three year approval for the revision of the National Notifiable Diseases Surveillance System (NNDSS) Information Collection Request (ICR), OMB Control No. 0920-0728, expiration date April 30, 2022. This application is the fourth revision to the previous application for 0920-0728 (approved by OMB on January 15, 2014) which consolidated four other CDC applications for nationally notifiable diseases case notification: Control Nos. 0920-0128, (Congenital Syphilis Surveillance), parts of 0920-0819 (Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance), parts of 0920-0009 (National Disease Surveillance Program - I. Case Reports) and parts of 0920-0004 (National Disease Surveillance Program - II. Disease Summaries). Consolidation of the information collection requests across multiple diseases has reduced the administrative costs of the OMB PRA application process and has resulted in increased standardization across the disease components of the application.
Key changes in this revision are enumerated in the table below:
Disease Name in NNDSS Collection |
Nationally Notifiable (NNC) OR Under Standardized Surveillance (CSS) |
Current Case Notification (Y/N) |
Proposed Case Notification (Y/N) |
Current Disease-specific Data Elements (Y/N) |
Proposed Disease-specific Data Elements (Y/N) |
Number of Existing Data Elements in NNDSS |
Proposed Number of new NNDSS Data Elements |
Blastomycosis |
CSS |
N |
Y |
N |
N |
0 |
0 |
2019 Novel Coronavirus Disease (COVID-19) |
NNC |
Y |
N |
N |
Y |
0 |
46 |
Carbon Monoxide (CO) Poisoning |
NNC |
Y |
|
Y |
Y |
4 |
45 |
Congenital Syphilis |
NNC |
Y |
|
Y |
Y |
89 |
2 |
STD (not congenital) |
NNC |
Y |
|
Y |
Y |
121 |
14 |
Background and Respondent Population
The NNDSS is the nation’s public health surveillance system that enables all levels of public health (local, state, territorial, federal and international) to monitor the occurrence and spread of the diseases and conditions that CDC and the Council of State and Territorial Epidemiologists (CSTE) officially designate as “nationally notifiable” or as under “standardized surveillance.” CSTE is an organization of member states and territories representing public health epidemiologists. CDC and CSTE determine which diseases and data elements should be monitored as part of national surveillance. New diseases and data elements under consideration for inclusion in NNDSS are described in CSTE position statements (authored by CDC and CSTE members) that are voted on by all participating local and state health departments at the CSTE annual meeting. The NNDSS program creates the infrastructure for the surveillance system and facilitates the submission and aggregation of case notification data voluntarily submitted to CDC from 60 jurisdictions: public health departments in every U.S. state, New York City, Washington DC, 5 U.S. territories (American Samoa, the Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the U.S. Virgin Islands), and 3 freely associated states (Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).
The NNDSS also facilitates relevant data management, analysis, interpretation and dissemination of the information. The data are used to monitor the occurrence of notifiable conditions and to plan and conduct prevention and control programs at the state, territorial, local and national levels.
CDC is responsible for the reporting and dissemination of nationally notifiable conditions’ information, as authorized by the Public Health Service Act (42 USC 241) of January 4, 2012 [Attachment 1. Authorizing Legislation].
A.2. Purpose and Use of the Information Collection
The NNDSS is a reporting platform for states and territories to voluntarily share with CDC the data that they collect from health care providers, medical laboratories and other related entities pursuant to state, territorial and local legislation and regulations. These locally reportable conditions, which include infectious and non-infectious diseases, vary by jurisdiction depending upon each jurisdiction’s health priorities and needs (as such, not all jurisdictions send CDC information on all conditions). These data at the state, territorial, and local levels are used to identify and monitor health impact of the reportable conditions in those communities, measure trends, identify populations or geographic areas at high risk, plan prevention and control programs and policies, allocate resources appropriately, and evaluate the effectiveness of programs and policies. Infectious disease agents and environmental hazards often cross geographical boundaries. The primary burden on the jurisdiction associated with this information collection stems from the initial cost of programming new conditions and data elements into the local jurisdiction’s reporting system for those diseases and conditions that the jurisdiction has made locally reportable.
Conditions are included in the NNDSS when CDC and CSTE agree that the condition is of sufficient public health significance to warrant the states and territories submitting case-based surveillance data to CDC to allow monitoring on a national level. Among the thousands of diseases that affect the population, only about 120 have been prioritized for inclusion in NNDSS. This collaborative relationship between CDC and the states began in 1903, when the US Surgeon General Walter Wyman presided over the first annual conference of state and territorial health officers and led a discussion about disease surveillance. By 1912, states developed a list of diseases that they deemed notifiable (5 immediately by telegraph and 10 monthly by letter) to the Surgeon General. Responsibility for developing consensus among the states on which health conditions the states would submit to CDC was given to the State Epidemiologists by CDC in the 1950s. State Epidemiologists convened for this reason in 1951 with the encouragement of Alexander Langmuir, Chief of the Bureau of Epidemiology at CDC1. CSTE was created and is funded by CDC to provide guidance on which conditions should be nationally notifiable or under standardized surveillance.
Each year, CSTE, supported by CDC, determines which reportable conditions should be designated nationally notifiable or under standardized surveillance. When states decide whether to make a condition reportable and when the CSTE membership and CDC decide whether to make a condition nationally notifiable, they consider the following issues: severity, incidence, communicability, preventability, impact on the community or society and need for public health action. CSTE position statements must be sponsored by a CSTE Active Member, specifically, a person engaged in the practice of epidemiology for a government public health authority at the local, tribal, state, and territorial level. The position statements are discussed and then reviewed at the CSTE national office. Next, a technical review by a select group of subject matter experts is done. The national office then shares the position statement with appropriate CSTE Executive Board members. The national office then circulates the draft position statement among voting members and the position statement is voted on at the Annual CSTE Conference. The final approved position statement is then published on the CSTE website. When CSTE approves a position statement placing a condition under standardized surveillance, this establishes standardized case definitions and surveillance methods for use by jurisdictions conducting surveillance for this condition and recommends that jurisdictions conducting surveillance share the case data with CDC if it is requested by the relevant CDC program. When CSTE takes the additional step of making a condition nationally notifiable, this expresses the consensus of the CSTE membership that all states and territories should enact laws or regulations to make this condition reportable in their jurisdictions and should voluntarily submit the data to CDC so that information can be shared across jurisdictional boundaries and so that surveillance and prevention and control activities can be coordinated at regional and national levels. CSTE, in conjunction with CDC, makes annual recommendations for additions and deletions to the list of conditions under standardized surveillance and nationally notifiable diseases.
Description of Conditions for which Case Notifications are Received
The nationally notifiable conditions and conditions under standardized surveillance that are received by CDC through NNDSS are listed in two attachments [Attachment 3. List of Nationally Notifiable Conditions and Attachment 4. List of Conditions Under Standardized Surveillance]. There is one condition (2019 Novel Coronavirus Disease (COVID-19) listed in Attachment 3 in bold that was not included in the previous ICR and another condition (Blastomycosis) listed in Attachment 4 in bold that was also not included in the previous ICR.
Detailed characteristics about the conditions including the reasons why the conditions are being added to NNDSS are described below:
CSTE issued a position statement in 2018 that rendered Blastomycosis under standardized surveillance (https://cdn.ymaws.com/www.cste.org/resource/resmgr/2019ps/final/19-ID-02_Blastomycosis_final.pdf).
This position statement includes the following statement: “Jurisdictions (e.g., States and Territories) conducting surveillance under this case definition can voluntarily submit de-identified case information to CDC, if requested and in a mutually agreed upon format.” CDC requests permission to receive case notification data for Blastomycosis as it is now under standardized surveillance.
Blastomycosis |
|
The impetus/urgency for CDC to institute case notification and data elements for this condition
|
Blastomycosis is a rare but serious and potentially deadly disease. Public health professionals have a limited understanding of its epidemiology and how and why sporadic cases and outbreaks occur. These data will inform understanding of risk factors, including geographic risk, and changing trends, allowing for improved public and medical outreach and clinical decision making, which are essential for reducing delays in diagnosis and treatment. |
Existing sources of data (Federal, non-federal, private, etc.) and what those sources say about approximate national incidence and/or prevalence of the condition
|
|
Incremental coverage provided by adding the condition to NNDSS (how CDC will use additional precision)
|
Blastomycosis is likely under-recognized. Until the newly-approved standardized surveillance case definition is implemented, inconsistencies in state-based reporting make it difficult to accurately estimate the disease’s true incidence and range. |
Number of states that currently require reporting of these conditions and data elements |
5 states |
The number of states anticipated to adopt if added to NNDSS and basis of estimate Funding allocated specifically for a condition and/or additional elements (please list source where applicable)
|
At least the 5 states where blastomycosis is currently reportable; possibly more. No specific funding allocated. |
Anticipated frequency of reporting to CDC |
Reporting should be all-inclusive, ongoing, and routine. Reporting should occur in a timeframe consistent with local jurisdiction rules. |
Based on the above information, what is the proposed priority associated with condition |
States will determine the priority of adding this collection. |
COVID-19
CDC received approval on January 23, 2020 for an Emergency Revision under 0920-0728 to receive case notification data for COVID-19 for 180 days. The World Health Organization (WHO) declared the COVID-19 outbreak a public health emergency of international concern on January 30, 2020 and the US Department of Health and Human Services (HHS) declared the COVID-19 outbreak a public health emergency on January 31, 2020. CSTE issued an interim position statement on April 5, 2020 that rendered COVID-19 nationally notifiable (https://cdn.ymaws.com/www.cste.org/resource/resmgr/2020ps/Interim-20-ID-01_COVID-19.pdf).
This position statement includes the following statement: “Jurisdictions (e.g. States and Territories) conducting surveillance (according to these methods) should submit case notifications to CDC.” CDC requests permission to receive case notification data for COVID-19 as it is now nationally notifiable.
2019 Novel Coronavirus (COVID-19) |
|
The impetus/urgency for CDC to institute case notification and data elements for this condition
|
|
Existing sources of data (Federal, non-federal, private, etc.) and what those sources say about approximate national incidence and/or prevalence of the condition
|
|
Incremental coverage provided by adding the condition to NNDSS (how CDC will use additional precision)
|
|
Number of states that currently require reporting of these conditions and data elements |
|
The number of states anticipated to adopt if added to NNDSS and basis of estimate Funding allocated specifically for a condition and/or additional elements (please list source where applicable)
|
|
Anticipated frequency of reporting to CDC |
|
Based on the above information, what is the proposed priority associated with condition |
|
Description of Data Elements Received
For each nationally notifiable condition or condition under standardized surveillance that a state, territorial, or local jurisdiction chooses to report to CDC, a common, core set of data elements is requested for each case. The core data elements include the name of the condition, demographic data for the person with the condition, epidemiologic data, and administrative data. All of these core data elements were included in the previously approved ICR. Names, descriptions and value set codes for the data elements are identified in an attachment [Attachment 5. Core Data]. Twelve of these core data elements are required for a valid case notification message. The rest of the core data elements are optional since the jurisdiction may not collect these data elements or the jurisdiction may not have the information for a particular case. If any one of the twelve data elements is not present in the message, the message cannot be processed by CDC and an error message will be generated. These 12 data elements are highlighted in yellow on Attachment 5. Core Data. The creation of a core set of data for each disease case report was an important accomplishment of NNDSS. It not only standardized case data coming into CDC but it promoted standardization across states as well. Other CDC surveillance programs are now incorporating the core data elements into their systems so that data at CDC will be interoperable and more shareable. And, during a public health emergency, it makes data collection and exchange more timely.
For each nationally notifiable condition or condition under standardized surveillance that a state, territorial, or local jurisdiction chooses to report to CDC, a common set of optional laboratory data elements is requested for each case. All of these laboratory data elements were included in the previously approved ICR. Names, descriptions and value set codes for the data elements are identified in an attachment [Attachment 6. Laboratory Data].
For each nationally notifiable condition or condition under standardized surveillance that a state, territorial, or local jurisdiction chooses to report to CDC, a common set of optional vaccine data elements is requested. All of these vaccine data elements were included in the previously approved ICR. Names, descriptions and value set codes for the data elements are identified in an attachment [Attachment 7. Vaccine Data].
For each vaccine preventable disease (VPD) that is nationally notifiable or under standardized surveillance that a state territorial, or local jurisdiction chooses to report to CDC, a common set of optional data elements are requested. All of these vaccine data elements were included in the previously approved ICR. Names, descriptions and value set codes for the data elements are identified in Attachment 8. Vaccine Preventable Disease Data.
Among the conditions established as nationally notifiable or under standardized surveillance, participating public health departments voluntarily submit requested data elements which are specific to each condition. These data elements are optional and are submitted in addition to the core set of data elements. With the coordination with the CDC programs conducting surveillance on nationally notifiable conditions, as noted above, this application includes disease-specific tables for 56 diseases. 107 new data elements that were not included in the previously reviewed ICR were added for 4 conditions: COVID-19, CO Poisoning, Congenital Syphilis, and STD (not congenital). Names, descriptions, value set codes, and justification for the addition of these new data elements are in Attachment 9. Justification for the Addition of Disease-Specific Data Elements. Names, descriptions and value set codes for all of the data elements are in an attachment [Attachment 10. Disease-Specific Data] with the new data elements identified in bold.
CDC and HHS are committed to minimizing the disease collection and submission burden for jurisdictions. This is accomplished by
Helping jurisdictions focus their surveillance efforts by providing guidance on which data elements are most important for disease monitoring and control;
Not requiring jurisdictions to send data elements that are not available for an individual, not included in the jurisdiction’s surveillance system, or not a priority for collection in the jurisdiction; and
Receiving this data through NNDSS, an existing infrastructure that supports automated messaging and that is already in use by public health jurisdictions to transmit case-based surveillance data from their jurisdiction surveillance systems to CDC.
A.3. Use of Improved Information Technology and Burden Reduction
An NNDSS initiative that focuses on using improved information technology is the NNDSS Modernization Initiative (NMI). NMI is part of the CDC Surveillance Strategy (http://www.cdc.gov/ophss/docs/cdc-surveillance-strategy-final.pdf) released in February 2014. NMI seeks to improve the use of information technology by implementing health information exchange industry standards for messaging and vocabulary. Since the epidemiology of some notifiable conditions has changed over time, new clinical information (e.g., laboratory tests and results, vaccination information, and treatment information) is needed for surveillance. Implementing these industry standards including Health Level 7 (HL7) electronic messaging allows the receipt of such information in a case notification message.
Approximately 90% of case notifications are sent to CDC by automated electronic HL7 or NETSS messages. However, NETSS messages are not based on industry standards. Some case notifications are still sent to CDC by non-automated mechanisms including email, secure file upload, and data entry to a secure website. These different mechanisms used to send case notifications to CDC vary by the jurisdiction and the disease or condition. As NMI advances, all public health departments will exclusively use HL7 messages to send case notification messages to CDC for all diseases and conditions. CDC continues to develop message mapping guides (MMGs) to describe and standardize the data content needed for electronic HL7 case notification.
Territories also participate in NMI. All 60 NNDSS jurisdictions (including territories and freely associated states) receive funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement (https://www.cdc.gov/ncezid/dpei/epidemiology-laboratory-capacity.html) and some of that funding is used to implement electronic integrated surveillance systems. Several of the territories are at some stage of implementing the National Electronic Disease Surveillance System (NEDSS) Base System (NBS) as their electronic integrated surveillance system that they will use to send automated HL7 case notifications to CDC. NBS is a CDC-developed integrated information system that helps local, state, and territorial public health departments manage reportable disease data and send notifiable disease data to CDC.
As NMI moves forward, opportunities exist to decrease the burden for public health departments that send case notification data to CDC. Implementation of more MMGs will reduce the burden since public health departments will not have to use different mechanisms that vary by disease or condition to send case notification messages to CDC. In addition, CDC is developing a dashboard that will display case notification data sent by jurisdictions. The dashboard will include the details of messages received and processed by CDC, as well as warnings and errors on messages that were submitted by jurisdictions but did not pass the structural, content, and business rules validation. As a result, jurisdictions will be able to use the dashboard to verify the number of messages received by CDC and to assist with the reconciliation of data throughout the year. This will decrease the burden from the annual data reconciliation effort. As the new messaging standards are developed through NMI implementation, there is a burden to the jurisdictions as they incorporate these new standards, although the end result is expected to reduce the overall burden. The limited duration effort required to implement the new standards is represented in the burden table as “NMI Implementation.”
A.4. Efforts to Identify Duplication and Use of Similar Information
No other Federal agency funds or conducts this type of surveillance, based on information on reportable conditions received by state, territorial, and local public health departments and notifications submitted by public health departments to CDC. Information obtained and maintained in NNDSS serves as a unique, centralized, integrated source of information about nationally notifiable conditions in the U.S. and the information is not available from any other source. As the DHIS NNDSS electronic systems are developed through NMI implementation to allow state and local public health departments to submit more nationally notifiable disease data to CDC, both the duplication of reporting to CDC by state and local public health departments and the burden to state and local public health departments may be reduced.
A.5. Impact on Small Businesses or Other Small Entities
This submission of information does not involve small businesses or other small entities.
A.6. Consequences of Collecting the Information Less Frequently
Public health departments that use automated methods to send case notifications to CDC send case notifications at least weekly. Most public health departments that use non-automated methods to send case notifications to CDC also send them at least weekly and some (territories and freely associated states) send them at least quarterly. The timeliness of these data is one of the most critical factors in the notification process. Rapid disease notification is an indispensable tool for public health officials at local, state, territorial and national levels, who use the data to monitor the occurrence and prevent the spread of the diseases. Less frequent notification does not allow timely assessment, particularly for emerging disease threats. Changes in disease distribution are continuously monitored so that appropriate investigations or interventions may be rapidly undertaken. In addition, rapid notification is also necessary to allow the United States to meet its obligations under the revised 2005 International Health Regulations to report important events that meet the criteria to be considered a public health emergency of international concern to the World Health Organization.
We are not aware of any legal obstacles to reducing the burden.
A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Collection of case notification data is conducted in a manner consistent with the guidelines in 5 CFR 1320.5. CDC requests that public health departments send case notification messages at least weekly if possible as justified under section A6.
A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A.8.A.
A 60-day Federal Register Notice was published in the Federal Register on November 4, 2019, Vol. 84, No. 213, pp. 59387-59389 [Attachment 2a. 60-Day FRN]. No comments were received.
A.8.B.
Through cooperative agreements, two independent external peer review panels conducted reviews of NNDSS. The report from the first panel was issued in December 2011 and focused on the results of an assessment of systems, frameworks and processes for infectious diseases within CDC. The report from the second panel was issued in April 2013 and focused on the results of a review of state and local systems, frameworks and processes for reportable conditions and for submission of information on notifiable infectious diseases to CDC. External consultants to the second independent external peer review panel, conducted by CSTE, are listed in the attachment [Attachment 11. Consultants List].
A.9. Explanation of Any Payment or Gift to Respondents
There are no payments or gifts provided to respondents.
A.10. Protection of the Privacy and Confidentiality of Information Provided by Respondents
NNDSS data are stored in the Data Warehouse (DW), Data Message Brokering (DMB) and the Message Validation, Processing, and Provisioning System (MVPS). HL7 case notifications that use older MMGs are processed by DMB, and HL7 messages that use newer MMGs are processed by MVPS. NETSS case notifications are processed in the DW which ultimately stores all electronic case notifications. The Privacy Act is applicable as personally identifiable information (PII) is collected and information can be retrieved by PII. However, data are not retrieved by PII. In addition, some combinations of submitted data elements could potentially be used to identify individuals. See Privacy Impact Assessments (PIAs) for the DW, DMB, and MVPS [Attachments 12 through 14]. Private information will not be disclosed unless otherwise compelled by law. No assurance of confidentiality has been obtained.
Case notifications include demographic, epidemiologic, administrative, vaccine, laboratory and disease-specific data related to a case of a nationally notifiable condition. The security of private information during automated transmission to NNDSS is maintained by the Department of Health and Human Services (HHS) standard encryption technologies (computers and servers) that use national public health standards for messaging systems which provide security mechanisms for jurisdictions to use when submitting data. Case notifications are encrypted and submitted to NNDSS electronically from already existing databases via automated electronic transfers through a secure network. Electronic data are transmitted to and securely processed at CDC. When automated transmission is not possible, case counts are emailed or uploaded to a secure network or entered into a secure website. Information that is emailed or uploaded is in the form of an aggregate weekly or annual case counts. Once in DHIS, all case notification data are treated in a secure manner consistent with the technical, administrative, and operational controls required by the Federal Information Security Management Act of 2002 (FISMA). These DHIS systems are also in compliance with more recent standards to protect information: the NIST Recommended Security Controls for Federal Information Systems and Organizations, Special Publication 800-53, Revised May 1, 2010.
As noted in A.2 above, for certain nationally notifiable conditions, CDC releases national data to the public through CDC’s web-based query system known as CDC WONDER (http://wonder.cdc.gov/. NNDSS data are also published on Data.CDC.gov (https://data.cdc.gov/) and DATA.GOV (http://www.data.gov/). Privacy is protected in a number of ways. CDC WONDER, Data.CDC.gov, and DATA.GOV only provide summary statistics of aggregate data to their users. Data for CDC WONDER are produced by CDC programs, which have already stripped the data of all PII before providing these public-use data sets to CDC WONDER. Furthermore, CDC WONDER dynamically imposes privacy and suppression constraints on all query results sets produced by the CDC WONDER web application, in compliance with each data set’s specific data use policy. CDC WONDER and Data.CDC.gov are also subject to and have met CDC’s Security Assessment and Authorization (SA&A) process, in which the CDC WONDER constraints are examined and validated by the CDC’s Office of the Chief Information Security Officer (OCISO). Only public use, non-PII data in the form of summary statistics are uploaded to Data.CDC.gov per OCISO policy. In addition, NNDSS data published on Data.CDC.gov are also published on DATA.GOV. Surveillance programs in OID and CGH have primary responsibility at CDC for surveillance of the infectious diseases and conditions covered by their Centers. Programs within these Centers receive nationally notifiable infectious disease data from DHIS and use, release and/or share their programs’ data according to guidance established by CDC, their Centers and programs.
A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions
IRB Approval
This activity does not require Institutional Review Board (IRB) documentation as this activity is public health practice (surveillance), not research [Attachment 15. NNDSS Research Determination].
Sensitive Questions
The NNDSS does not ask questions of a sensitive nature, but information is submitted about sensitive topics, including whether a patient has sexually transmitted diseases and sexual and drug-using behaviors. The NNDSS must receive information about sensitive notifiable diseases in order to monitor the occurrence of the diseases so that effective prevention and control programs can be planned and implemented.
A.12. Estimates of Annualized Burden Hours and Costs
As stated in A.1 above, this application is the fourth revision to the previous application for 0920-0728 (approved by OMB on January 15, 2014) which consolidated Control No. 0920-0128, parts of 0819, 0009, and 0004, into Control No. 0920-0728.
The burden estimates in Table A12A below include the estimates of burden hours for the key changes in this revision including:
1) the one-time increase in burden hours that states, territories, freely associated states, and cities will incur to send case notification data for Blastomycosis; and 2) the one-time increase in burden hours that states, territories, freely associated states, and cities will incur to process and send a total of 107 new data elements for 4 conditions: COVID-19, CO Poisoning, Congenial Syphilis, and STD (not congenital). The one-time burden to add COVID-19 to NNDSS was accounted for in the Emergency Revision for 0920-0728 to receive case notifications for COVID-19 for 180 days (approved on January 23, 2020). The burden to continue to receive case notification data for COVID-19 after the previously approved 180-day period is included in the weekly and annual burden hour estimates.
The burden estimates are shown for four types of respondents: states, territories, freely associated states, and cities. Attachment 16. Burden Table Calculations describes the burden table calculations in detail.
States
States incur burden by: 1) sending weekly automated case notification data to CDC, 2) sending weekly non-automated case notification data to CDC, 3) modernizing their surveillance systems as part of NMI implementation, 4) reconciling and sending annual case notification data to CDC, and 5) modifying their surveillance systems and automated case notification messages to accommodate new data elements and diseases. All 50 states send weekly automated case notification data to CDC for at least one disease or condition and their average burden is 20/60 hours. 10 states send weekly non-automated case notification data to CDC for at least one disease or condition and their average burden is 2 hours. All 50 states perform weekly activities to modernize their surveillance systems as part of NMI implementation and their average burden is 4 hours. All 50 states reconcile and send annual case notification data to CDC and their average burden is 75 hours. All 50 states modify their surveillance systems and automated case notification messages to accommodate new data elements. As shown on the Total Diseases + Data Elements tab on Attachment 16. Burden Table Calculations, the one-time average burden per response is 5 hours and the one-time total burden is 250 hours. As shown on Table A12A below, the annualized one-time average burden per response is 3 hours and the annualized one-time total burden is 150 hours.
Territories
Territories incur burden by: 1) sending weekly automated case notification data to CDC, 2) sending weekly and quarterly non-automated case notification data to CDC, 3) modernizing their surveillance systems as part of NMI implementation, 4) reconciling and sending annual case notification data to CDC and 5) modifying their surveillance systems and automated case notification messages to accommodate new data elements and diseases. All 5 territories send weekly automated case notification data to CDC for at least one disease or condition and their average burden is 20/60 hours. All 5 territories send weekly and quarterly non-automated case notification data to CDC for at least one disease or condition and their average burden per response is 20/60 hours. All 5 territories perform weekly activities to modernize their surveillance systems as part of NMI implementation and their average burden is 4 hours. All 5 territories reconcile and send annual case notification data to CDC and their average burden is 5 hours. All 5 territories modify their surveillance system and automated case notification message to accommodate new data elements and diseases. As shown on the Total Diseases + Data Elements tab on Attachment 16. Burden Table Calculations, the one-time average burden per response is 5 hours and the one-time total burden is 25 hours. As shown on Table A12A below, the annualized one-time average burden per response is 3 hours and the annualized one-time total burden is 15 hours.
Freely Associated States
Freely associated states incur burden by: 1) sending weekly automated case notification data to CDC, 2) sending weekly and quarterly non-automated case notification data to CDC, 3) reconciling and sending annual case notification data to CDC and 4) modifying their surveillance systems and automated case notification messages to accommodate new data elements and diseases. All 3 freely associated states send weekly automated case notification data to CDC for at least one disease or condition and their average burden is 20/60 hours. All 3 freely associated states send weekly and quarterly non-automated case notification data to CDC for at least one disease or condition and their average burden is 20/60 hours. All 3 freely associated states reconcile and send annual case notification data to CDC and their average burden is 5 hours. All 3 freely associated states modify their surveillance systems and automated case notification message to accommodate new data elements and diseases. As shown on the Total Diseases + Data Elements tab on Attachment 16. Burden Table Calculations, the one-time average burden per response is 5 hours and the one-time total burden is 15 hours. As shown on Table A12A below, the annualized one-time average burden per response is 3 hours and the annualized one-time total burden is 9 hours.
Cities
Cities incur burden by: 1) sending weekly automated case notification data to CDC, 2) sending weekly non-automated case notification data to CDC, 3) modernizing their surveillance systems as part of NMI implementation, 4) reconciling and sending annual case notification data to CDC, and 5) modifying their surveillance systems and automated case notification messages to accommodate new data elements and diseases. Both of the 2 cities send weekly automated case notification data to CDC for at least one disease or condition and their average burden is 20/60 hours. Both of the 2 cities send weekly non-automated case notification data to CDC for at least one disease or condition and their average burden per response is 2 hours. Both of the 2 cities perform weekly activities to modernize their surveillance systems as part of NMI implementation and their average burden is 4 hours. Both of the 2 cities reconcile and send annual case notification data to CDC and their average burden is 75 hours. Both of the 2 cities modify their surveillance systems and automated case notification messages to accommodate new data elements and diseases. As shown on the Total Diseases + Data Elements tab on Attachment 16. Burden Table Calculations, the one-time average burden per response is 5hours and the one-time total burden is 10 hours. As shown on Table A12A below, the annualized one-time average burden per response is 3 hours and the annualized one-time total burden is 6 hours.
According to the U.S. Department of Labor, Bureau of Labor Statistics, Occupational Employment Statistics, May 2019 National Occupational Employment and Wage Estimates, the estimated mean hourly wage for Computer Systems Analysts is $46.23 (https://www.bls.gov/oes/current/oes_nat.htm#15-0000) and the estimated mean hourly wage for Epidemiologists is $37.64 (http://www.bls.gov/oes/current/oes_nat.htm#19-0000) The estimated hourly wage for a Computer Systems Analyst is used for weekly automated submissions and weekly NMI implementation activities and the estimated hourly wage for an Epidemiologist is used for weekly non-automated submissions and annual data reconciliation. These wage estimates were used because these two occupations represent the category of occupations held by the respondents that perform these activities. Using $46.23 as an average hourly wage rate for Computer Systems Analysts and using $37.64 as an average hourly wage rate for Epidemiologists, it is estimated that the average national annual burden for weekly and annual reporting is 18,414 hours at a national cost of $805,434.
A12A. Estimates of Annualized Burden Hours
Type of Respondents |
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Burden (in hours) |
States |
Weekly (Automated) |
50 |
52 |
20/60 |
867 |
States |
Weekly (Non- automated) |
10 |
52 |
2 |
1,040 |
States |
Weekly (NMI Implementation) |
50 |
52 |
4 |
10,400 |
States |
Annual |
50 |
1 |
75 |
3,750 |
States |
One-time Addition of Diseases and Data Elements |
50 |
1 |
3 |
150 |
Territories |
Weekly (Automated) |
5 |
52 |
20/60 |
87 |
Territories |
Weekly, Quarterly (Non-automated) |
5 |
56 |
20/60 |
93 |
Territories |
Weekly (NMI Implementation) |
5 |
52 |
4 |
1,040 |
Territories |
Annual |
5 |
1 |
5 |
25 |
Territories |
One-time Addition of Diseases and Data Elements |
5 |
1 |
3 |
15 |
Freely Associated States |
Weekly (Automated) |
3 |
52 |
20/60 |
52 |
Freely Associated States |
Weekly, Quarterly (Non-automated) |
3 |
56 |
20/60 |
56 |
Freely Associated States |
Annual |
3 |
1 |
5 |
15 |
Freely Associated States |
One-time Addition of Diseases and Data Elements |
3 |
1 |
3 |
9 |
Cities |
Weekly (Automated) |
2 |
52 |
20/60 |
35 |
Cities |
Weekly (Non-automated) |
2 |
52 |
2 |
208 |
Cities |
Weekly (NMI Implementation) |
2 |
52 |
4 |
416 |
Cities |
Annual |
2 |
1 |
75 |
150 |
Cities |
One-time Addition of Diseases and Data Elements |
2 |
1 |
3 |
6 |
Total |
|
|
|
|
18,414 |
A12B. Estimates of Annualized Cost Burden
Type of Respondents |
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Burden Hours |
Hourly Wage Rate |
Respondent Cost |
States
|
Weekly (Automated) |
50 |
52 |
20/60 |
867 |
$46.23 |
$40,081 |
States
|
Weekly (Non-automated) |
10 |
52 |
2 |
1,040 |
$37.64 |
$39,146 |
States |
Weekly (NMI Implementation) |
50 |
52 |
4 |
10,400 |
$46.23 |
$480,792 |
States |
Annual |
50 |
1 |
75 |
3,750 |
$37.64 |
$141,150 |
States |
One-time Addition of Diseases and Data Elements |
50 |
1 |
2 |
150 |
$46.23 |
$6,935 |
Territories
|
Weekly (Automated) |
5 |
52 |
20/60 |
87 |
$46.23 |
$4,022 |
Territories
|
Weekly, Quarterly (Non-automated) |
5 |
56 |
20/60 |
93 |
$37.64 |
$3,501 |
Territories |
Weekly (NMI Implementation) |
5 |
52 |
4 |
1,040 |
$46.23 |
$48,079 |
Territories |
Annual |
5 |
1 |
5 |
25 |
$37.64 |
$941 |
Territories |
One-time Addition of Diseases and Data Elements |
5 |
1 |
2 |
15 |
$46.23 |
$693 |
Freely Associated States |
Weekly (Automated) |
3 |
52 |
20/60 |
52 |
$46.23 |
$2,404 |
Freely Associated States |
Weekly, Quarterly (Non-automated) |
3 |
56 |
20/60 |
56 |
$37.64 |
$2,108 |
Freely Associated States |
Annual |
3 |
1 |
5 |
15 |
$37.64 |
$565 |
Freely Associated States |
One-time Addition of Diseases and Data Elements |
3 |
1 |
2 |
9 |
$46.23 |
$416 |
Cities |
Weekly (Automated) |
2 |
52 |
20/60 |
35 |
$46.23 |
$1,618 |
Cities |
Weekly (Non-automated) |
2 |
52 |
2 |
208 |
$37.64 |
$7,829 |
Cities
|
Weekly (NMI Implementation) |
2 |
52 |
4 |
416 |
$46.23 |
$19,232 |
Cities |
Annual |
2 |
1 |
75 |
150 |
$37.64 |
$5,646 |
Cities |
One-time Addition of Diseases and Data Elements |
2 |
1 |
2 |
6 |
$46.23 |
$277 |
Total |
|
|
|
|
|
|
$805,434 |
A.13. Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no other annual costs to respondents or record keepers.
A.14. Annualized Cost to the Federal Government
Item |
NNDSS Estimated Cost to Federal Government |
||
|
FY 18 |
FY 19 |
FY 20 |
Personnel - Software development, support, and management (intramural) |
$5,752,673 |
$5,484,199 |
$6,770,737 |
Contracts – Program and web support |
$7,717,254 |
$9,943,144 |
$8,162,080 |
Cooperative Agreements with States for NNDSS case notification and management (extramural) |
$10,676,869 |
$9,388,955 |
$7,355,955 |
Total |
$24,146,796 |
$24,816,298 |
$22,288,772 |
The estimated annualized cost to the government for NNDSS is $23,750,622 (average of three years).
A.15. Explanation for Program Changes or Adjustments
Changes to NNDSS in this revision include receipt of case notification data for Blastomycosis which is now under standardized surveillance, receipt of case notification data for COVID-19 (which is now nationally notifiable) beyond the previously approved 180-day period, and receipt of disease-specific data elements for COVID-19, CO Poisoning, Congenital Syphilis, and STD (not congenital).
The overall burden hours decreased since the last revision because there were fewer one-time burdens associated with diseases and disease-specific data elements in this revision (2 diseases and 107 disease-specific data elements) as compared to the last revision (7 diseases and 451 disease-specific data elements). Going forward, there will be a one-time increase in the burden estimates each time new data elements or new conditions are added. The one-time increase in the burden estimates for adding new data elements will continue to be reflected as a separate line in the burden table in an ICR revision or a non-substantive change request.
A.16. Plans for Tabulation and Publication and Project Time Schedule
CDC tabulates and publishes provisional counts of nationally notifiable conditions each week. In the past, these data were published in the MMWR and were available through CDC WONDER and data.cdc.gov. Beginning in 2018, the weekly tables of nationally notifiable diseases have not been published in the MMWR but are available through CDC WONDER and data.cdc.gov. The MMWR Summary of Notifiable Diseases, United States, 2015, was the last summary of finalized notifiable disease data that was published by MMWR. Going forward and beginning with 2016 data, finalized notifiable disease data are published on CDC WONDER and disease-specific data are published by individual CDC programs. This transition to using CDC WONDER and CDC.data.gov as the primary forums for presentation of weekly tables allows CDC to finalize and publish annual data more quickly. In addition, CDC programs routinely publish reports on specific notifiable conditions in the MMWR and in other scientific, medical and public health journals.
CDC would like to implement an anticipated schedule of non-substantive change requests and revisions for NNDSS. Notifiable disease data collection is continuous, data are collected on approximately 120 conditions, and the epidemiology of these conditions is continuously evolving. As such, this information collection will continue to evolve to provide the knowledge needed for effective disease tracking and control. Many disease-specific messages need to be modernized as programs continue to convert disease notifications to Health Level 7 (HL7) messages, and each requires a substantial investment of time. This proposed schedule allows the production of a few updated messages with new data elements three times per year through routine non-substantive change requests as well as other substantive changes once per year through a revision (a revision may also include the addition of new data elements that were not added through a non-substantive change request but the need to add new data elements will not trigger the initiation of a revision). In addition to the proposed schedule for updated messages, requests for new data elements are occasionally received from programs to reflect changes in the epidemiology of the condition or the laboratory tests available for detection and diagnosis. These requests will usually be grouped into non-substantive change requests or added to the annual revision. However, when urgent situations arise, such as the need to make a new condition notifiable in response to an emergent outbreak, there may be additional revisions or non-substantive change requests outside of the proposed schedule.
CDC will notify OMB of all non-substantive change requests and revisions in advance. CDC will notify OMB of routine non-substantive change requests through memorandums and CDC will notify OMB of urgent non-substantive change requests and revisions through telephone briefings.
An anticipated schedule for submission of non-substantive change requests and revisions is presented in the table below:
Submission Type |
Purpose |
Approximate Frequency |
Approximate Timeline |
Non-substantive change request |
|
|
|
Revision |
|
|
|
*A revision may include the addition of new data elements that were not added through a non-substantive change request but the need to add new data elements will not trigger the initiation of a revision
A.17. Reason(s) Display of OMB Expiration Date is Inappropriate
Since approximately 90% of case notifications are submitted to CDC electronically from already existing databases via automated electronic transfers, CDC requests approval to place the PRA burden statement and OMB expiration date on the NNDSS Data Collection and Reporting webpage. Respondents can navigate to the list of required data elements from this central location. A screenshot of the webpage is shown in Attachment 17. PRA Burden Statement Screenshot.
A.18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
1 Koo, D., & Wetterhall S. (1996). History and Current Status of the National Notifiable Diseases Surveillance System. Journal of Public Health Management and Practice, 2(4), 4-10.
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