2024-06094. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an Emergency Response. This information collection will allow 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.

DATES:

CDC must receive written comments on or before May 21, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. CDC–2024–0021 by either of the following methods:

• Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21–8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal ( www.regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21–8, Atlanta, Georgia 30329; Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. 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 submissions of responses; and

5. Assess information collection costs.

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), 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 the National Notifiable Diseases Surveillance System (NNDSS), 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. The estimated annual burden for the 60 respondents is 10,951 hours. 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)	Total burden (in hours)
States	Submission of case data	50	365	30/60	9,125
Territories	Submission of case data	5	365	30/60	913
Freely Associated States	Submission of case data	3	365	30/60	548
Cities	Submission of case data	2	365	30/60	365
Total					10,951

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.