Notice2023-13573
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 27, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 122 (Tuesday, June 27, 2023)</title>
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[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41629-41630]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#224d4f40624146410c454d54"><span class="__cf_email__" data-cfemail="2847454a684b4c4b064f475e">[email protected]</span></a>.
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]
BILLING CODE 4163-18-P
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