Proposed Data Collection Submitted for Public Comment and Recommendations, 65358-65359 [2024-17764]

Download as PDF 65358 Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices 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. 2024–17765 Filed 8–8–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–24–24HD; Docket No. CDC–2024– 0054] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: 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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Adverse Health Outcomes Associated with Medical Tourism Surveillance System. This information collection project will help CDC detect outbreaks and trends in cases to identify prevention measures and improve awareness of risks associated with medical tourism. DATES: CDC must receive written comments on or before October 8, 2024. ADDRESSES: You may submit comments, identified by Docket No. CDC–2024– 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. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:21 Aug 08, 2024 Jkt 262001 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. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Proposed Project Adverse Health Outcomes Associated with Medical Tourism Surveillance System—New—National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Millions of Americans travel abroad each year to get medical care. This practice of medical tourism is increasing, with even some U.S.-based health insurance companies sending patients abroad for medical care. Medical tourism has been associated with a variety of adverse health outcomes including serious infection, importation of antibiotic-resistant pathogens to the United States, and death. Outbreaks among medical tourists can be difficult to identify for many reasons. Complications from treatment(s) and procedure(s) obtained abroad are underreported by U.S. healthcare facilities. Jurisdictions throughout the United States have varying policies on reporting medical tourism-related adverse health events to CDC that can lead to underreporting from some jurisdictions. Infections acquired from health care abroad may not be locally or nationally reportable. Currently, there is no national surveillance system or mechanism for states to link cases between jurisdictions for medical tourism-related adverse health outcomes. This makes it difficult to identify patients with exposures linked to the same clinic or provider abroad since they will be returning to different parts of the United States. Collaboration with state and local health departments is essential to detect outbreaks, and as a federal entity, CDC can fulfill this role. The information collected through this surveillance system will help CDC detect outbreaks and trends in cases to identify prevention measures and improve awareness of risks associated with medical tourism. State and local health departments will conduct surveys and send them electronically to CDC. Data collected will be stored in an electronic database and will be extracted for further analysis. CDC requests OMB approval for an estimated 438 annual burden hours. There are no costs to respondents other than their time. E:\FR\FM\09AUN1.SGM 09AUN1 65359 Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Form name State/Local Health department staff Form 1 Medical Tourism Case Intake Form (Part B-Medical Chart Abstraction). Form 1 Medical Tourism Case Intake Form (Part A-Interviews). Ill persons who have experienced an adverse health outcome related to medical tourism. Ill persons who have experienced an adverse health outcome related to medical tourism. Total .......................................... 5/60 63 750 1 10/60 125 Form 2 Medical Tourism Enhanced Surveillance Form. 500 1 30/60 250 .......................................................... ........................ .......................... ........................ 438 BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10147 and CMS–10905] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 Total burden hours 15 [FR Doc. 2024–17764 Filed 8–8–24; 8:45 am] 19:21 Aug 08, 2024 Average burden per response (in hours) 50 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. VerDate Sep<11>2014 Number of responses per respondent Number of respondents Type of respondents Jkt 262001 information technology to minimize the information collection burden. DATES: Comments must be received by October 8, 2024. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 CMS–10147 Medicare Drug Coverage and Your Rights CMS–10905 Service Level Data Collection for Initial Determinations and Appeals Under the 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. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collections 1. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Medicare Drug Coverage and Your Rights; Use: Section 423.562(a)(3) and an associated regulatory provision at § 423.128(b)(7)(iii) require that Part D plan sponsors’ network pharmacies provide Part D enrollees with a printed copy of our standardized pharmacy notice ‘‘Medicare Drug Coverage and Your Rights’’ (hereafter, ‘‘notice’’) if an enrollee’s prescription cannot be filled. The purpose of this notice is to provide enrollees with information about how to contact their Part D plans to request a coverage determination, including a request for an exception to the Part D plan’s formulary. The notice reminds enrollees about certain rights E:\FR\FM\09AUN1.SGM 09AUN1

Agencies

[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65358-65359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-24HD; Docket No. CDC-2024-0054]


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 proposed information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Adverse Health Outcomes Associated with Medical Tourism 
Surveillance System. This information collection project will help CDC 
detect outbreaks and trends in cases to identify prevention measures 
and improve awareness of risks associated with medical tourism.

DATES: CDC must receive written comments on or before October 8, 2024.

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

    Adverse Health Outcomes Associated with Medical Tourism 
Surveillance System--New--National Center for Emerging Zoonotic and 
Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Millions of Americans travel abroad each year to get medical care. 
This practice of medical tourism is increasing, with even some U.S.-
based health insurance companies sending patients abroad for medical 
care. Medical tourism has been associated with a variety of adverse 
health outcomes including serious infection, importation of antibiotic-
resistant pathogens to the United States, and death. Outbreaks among 
medical tourists can be difficult to identify for many reasons. 
Complications from treatment(s) and procedure(s) obtained abroad are 
underreported by U.S. healthcare facilities. Jurisdictions throughout 
the United States have varying policies on reporting medical tourism-
related adverse health events to CDC that can lead to underreporting 
from some jurisdictions. Infections acquired from health care abroad 
may not be locally or nationally reportable. Currently, there is no 
national surveillance system or mechanism for states to link cases 
between jurisdictions for medical tourism-related adverse health 
outcomes. This makes it difficult to identify patients with exposures 
linked to the same clinic or provider abroad since they will be 
returning to different parts of the United States.
    Collaboration with state and local health departments is essential 
to detect outbreaks, and as a federal entity, CDC can fulfill this 
role. The information collected through this surveillance system will 
help CDC detect outbreaks and trends in cases to identify prevention 
measures and improve awareness of risks associated with medical 
tourism. State and local health departments will conduct surveys and 
send them electronically to CDC. Data collected will be stored in an 
electronic database and will be extracted for further analysis.
    CDC requests OMB approval for an estimated 438 annual burden hours. 
There are no costs to respondents other than their time.

[[Page 65359]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                    Number of     Average burden
     Type of respondents           Form name        Number of     responses per    per response    Total burden
                                                   respondents      respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
State/Local Health department  Form 1 Medical                50               15            5/60              63
 staff.                         Tourism Case
                                Intake Form
                                (Part B-Medical
                                Chart
                                Abstraction).
Ill persons who have           Form 1 Medical               750                1           10/60             125
 experienced an adverse         Tourism Case
 health outcome related to      Intake Form
 medical tourism.               (Part A-
                                Interviews).
Ill persons who have           Form 2 Medical               500                1           30/60             250
 experienced an adverse         Tourism
 health outcome related to      Enhanced
 medical tourism.               Surveillance
                                Form.
                                                ----------------------------------------------------------------
    Total....................  ................  ..............  ...............  ..............             438
----------------------------------------------------------------------------------------------------------------


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. 2024-17764 Filed 8-8-24; 8:45 am]
BILLING CODE 4163-18-P


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