2023-20759. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Chronic Q Fever in the United States: Enhanced Clinical Surveillance” 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 June 27, 2023 to obtain comments from the public and affected agencies. CDC received no comments 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

Chronic Q Fever in the United States: Enhanced Clinical Surveillance (OMB Control No. 0920–1305, Exp. 9/30/2023)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Q fever is a worldwide zoonosis caused by Coxiella burnetii with acute and chronic disease presentations. Chronic Q fever can manifest months to years after the primary infection and is rare, occurring in <5% of persons with an acute infection. Chronic Q fever can take on several clinical forms, including endocarditis, chronic hepatitis, chronic vascular infections, osteomyelitis, and osteoarthritis. In the United States, Q fever cases are reported via the National Notifiable Disease Surveillance System; however, limited information is collected on the various clinical manifestations of chronic Q fever or patients pre-existing risk factors. Data on outcomes other than death or hospitalizations are not collected by the current surveillance. Because of this lack of data, the true burden and proportion of cases exhibiting endocarditis and other forms of chronic Q fever in the United States is unknown. We plan to establish an enhanced medical surveillance for chronic Q fever by working with consulting clinicians to gather additional and more specific clinical data not otherwise collected during the course of routine public health surveillance for chronic Q fever. This information will allow for better characterization of the clinical presentation and risk factors of chronic Q fever in the United States. The results will help characterize an under-recognized disease and provide valuable data to educate physicians on identifying and diagnosing these cases.

Recently, there has been an increased volume of clinical consultation requests. To reflect this, we are proposing an increase in the number of respondents to 50 each year. Additionally, the clinical course for these patients is often complex, and clinical relapse or prolonged infection has been reported. To capture these important clinical details, we propose increasing the number of total instruments to two, with a follow-up survey that will take five minutes each at six, 12, 18, and 24 months from the date of the initial consult.

CDC requests OMB approval for an estimated 34 annual burden hours. There is no cost to respondents other than their time to participate.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Physician	Chronic Q fever Enhanced Surveillance Report Form—Initial Consult	50	1	20/60
Physician	Chronic Q fever Enhanced Surveillance Report Form—Follow-up	50	2	10/60

Jeffrey M. Zirger,

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