[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41629-41630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-1305; Docket No. CDC-2023-0054]


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.

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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 continuing information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled ``Chronic Q fever in the United States: Enhanced Clinical 
Surveillance''. This enhanced medical surveillance for chronic Q fever 
will collect specific clinical data not otherwise collected during 
routine public health surveillance to allow for better characterization 
of the clinical presentation and risk factors of chronic Q fever in the 
United States.

DATES: CDC must receive written comments on or before August 28, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0054 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: 404-639-7570; 
Email: [email protected].

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

    Chronic Q fever in the United States: Enhanced Clinical 
Surveillance (OMB Control No. 0920-1305, Exp. 9/30/2023)--Revision--
National Center for Emerging Zoonotic and 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 (NNDSS, OMB Control No. 0920-
0728); 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

[[Page 41630]]

months from the date of the initial consult. CDC requests OMB approval 
for an estimated 26 annual burden hours. There is no cost to 
respondents other than their time to participate.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
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Physician......................................  Chronic Q Fever Enhanced Surveillance                50               1           20/60              17
                                                  Report Form--Initial Consult.
Physician......................................  Chronic Q Fever Enhanced Surveillance                50               2            5/60               9
                                                  Report Form--Follow-Up.
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    Total......................................  .......................................  ..............  ..............  ..............              26
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-13573 Filed 6-26-23; 8:45 am]
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