Agency Forms Undergoing Paperwork Reduction Act Review

Download PDF
Federal RegisterSep 12, 2024
89 Fed. Reg. 74276 (Sep. 12, 2024)
Document Headings

Document headings vary by document type but may contain the following:

  • the agency or agencies that issued and signed a document
  • the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
  • the agency docket number / agency internal file number
  • the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions
  • See the Document Drafting Handbook for more details.

    Department of Health and Human Services Centers for Disease Control and Prevention
  • [30Day-24-24DU]
  • In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an Emergency Response” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March 22, 2024 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

    (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (c) Enhance the quality, utility, and clarity of the information to be collected;

    (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an Emergency Response—New—Office of Public Health Data, Surveillance, and Technology (OPHDST), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    During a public health emergency response, state, tribal, local, and territorial (STLT) health departments and CDC need to exchange data on confirmed, probable, and suspected cases rapidly. Timely notifications of cases from STLT to CDC are critical to provide situational awareness at the federal level to support decision making, particularly for public health threats that escalate quickly and cross jurisdictions. To this end, collecting the minimum data necessary will provide standardization and consistency among technical approaches and Agency-wide processes. The harmonization across CDC programs and STLTs will reduce the burden on STLTs and healthcare providers from ad hoc requests for case data from CDC programs.

    Section 319D of the Public Health Service Act (as amended Through Pub. L. 118-35, enacted January 19, 2024) states that CDC shall define the minimum data necessary as the Agency collaborates with STLTs and other partners to improve the appropriate near real-time electronic transmission of interoperable public health data for situational awareness and response to public health emergencies. In addition, the CDC Advisory Committee to the Director (ACD) recommends that CDC should establish the minimum data necessary for core data sources including case data to be transmitted to CDC from STLTs.

    CDC requests a three-year approval for a new Generic Information Collection Request (ICR), Clearance for the Collection of Minimal Data Necessary for Case Data During an Emergency Response. This new ICR includes a request for approval for CDC to collect the minimum data necessary for confirmed, probable, and suspected cases of any disease or condition that is the subject of an emergency response. Data may be sent to CDC by STLT Health Departments through Data Collation and Integration for Public Health Event Response (DCIPHER) or other automated or non-automated mechanisms including but not limited to fax, email, secure file upload, and data entry to a secure website.

    Data will be used for ongoing situational awareness and to monitor the occurrence and spread of the disease or condition. Other uses may include identifying populations or geographic areas at high risk; planning prevention and control programs and policies; and allocating resources appropriately. The data may also be used by CDC to obtain travel histories and other information to describe and manage outbreaks and conduct public health follow-up to minimize the spread of disease. The burden estimates include the time that states, territories, freely associated states, and cities will incur to submit confirmed, probable, and suspected case data for diseases or conditions that are the subject of an emergency response.

    CDC requests OMB approval for an estimated 10,951 annualized burden hours for the 60 respondents. There is no cost to respondents other than their time to participate.

    Estimated Annualized Burden Hours

    Type of respondent Form name Number of respondents Number of responses per respondent Average burden per response (in hours)
    States Submission of case data 50 365 30/60
    Territories Submission of case data 5 365 30/60
    Freely Associated States Submission of case data 3 365 30/60
    Cities Submission of case data 2 365 30/60