2024-12236. 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 Information Collection for Tuberculosis Data from Panel Physicians. The data collection is designed to collect tuberculosis (TB) data from medical exams of U.S.—bound immigrants and refugees who seek permanent residence in the U.S.

DATES:

CDC must receive written comments on or before August 5, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2024-0047 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

Information Collection for Tuberculosis Data from Panel Physicians (OMB Control No. 0920-1102, Exp. 12/31/2024))—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention's (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration Health (DGMH), Immigrant and Refugee Health Branch (IRHB), requests approval for a Revision of an existing information collection. This project pertains to collecting annual reports on certain tuberculosis (TB) data from U.S. panel physicians.

The respondents for this data collection are panel physicians. More than 760 panel physicians from 336 panel sites perform overseas pre-departure medical examinations in accordance with requirements, referred to as Technical Instructions (TI), provided by DGMH's Quality Assessment Program (QAP). The role of QAP is to assist and guide panel physicians in the implementation of the TI; to evaluate the quality of the overseas medical examination for U.S.-bound immigrants and refugees; to assess potential panel physician sites; and to provide recommendations to the U.S. Department of State in matters of immigrant medical screening.

To achieve DGMH's mission, the IRHB works with domestic and international programs to improve the health of U.S.-bound immigrants and refugees to protect the U.S. public by preventing the importation of infectious disease. These goals are accomplished through IRHB's oversight of medical exams required for all U.S.—bound immigrants and refugees who seek permanent residence in the U.S. IRHB is responsible for assisting and training the international panel physicians with the implementation of medical exam TI. The TIs are detailed requirements and national policies regarding the medical screening and treatment of all U.S.-bound immigrants and refugees.

Screening for TB is a particularly important component of the immigration medical exam and allows panel physicians to diagnose active TB disease prior to arrival in the United States. As part of the TI requirements, panel physicians perform chest x-rays and laboratory tests that aid in the identification of TB infection (Class B1 applicants) and diagnosis of active TB disease (Class A, inadmissible applicants). CDC uses these classifications to report new immigrant and refugee arrivals with a higher risk of developing TB disease to U.S. State and local health departments for further follow-up. Some information that panel physicians collect as part of the medical exam is not reported on the standard Department of State forms (DS-forms), thereby preventing CDC from evaluating TB trends in globally mobile populations and monitoring program effectiveness.

Currently, CDC is requesting this data be sent by panel physicians once per year. The consequences of reducing this frequency would be the loss of monitoring program impact and TB burdens in mobile populations and immigrants and refugees coming to the United States on an annual basis. A prior estimate of 7.5 hours has been reduced to three hours based on the knowledge that most panel physicians have established electronic tracking systems since the last OMB approval period, thereby reducing the amount of time needed to report this data to CDC. CDC has also reduced burden by removing four variables related to pending lab results since the last OMB approval period. The introduction of a web-based data collection tool using REDCap will reduce the burden by improving the efficiency of data reporting and reducing the time to fill out the previous excel spreadsheet and send via email. This new web-based data collection will improve efficiencies by having built in validation rules that will reduce potential data reporting errors. The new web-based data collection tool will be easier for panel physicians to submit data back to CDC by hitting submit rather than emailing a spreadsheet back.

Based on improved IT capacity at most panel sites and an overall reduction in variables collected since the last OMB approval period, the updated annual burden hours is decreased. The annual burden hours requested is 999. There is no cost to the respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
International Panel Physicians (All sites)	TB Indicators REDCap web form	333	1	3	999
Total					999

Jeffrey M. Zirger,

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