88 FR 122 pgs. 41629-41630 - Proposed Data Collection Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 88Number: 122Pages: 41629 - 41630
Pages: 41629, 41630Docket number: [60Day-23-1305; Docket No. CDC-2023-0054]
FR document: [FR Doc. 2023-13573 Filed 6-26-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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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.
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: omb@cdc.gov.
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.
[top] 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
| Type of respondents | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours) | Total burden (in hours) |
|---|---|---|---|---|---|
| Physician | Chronic Q Fever Enhanced Surveillance Report Form-Initial Consult | 50 | 1 | 20/60 | 17 |
| Physician | Chronic Q Fever Enhanced Surveillance Report Form-Follow-Up | 50 | 2 | 5/60 | 9 |
| Total | 26 |
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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