Proposed Data Collection Submitted for Public Comment and Recommendations, 3548-3549 [2022-01262]

Download as PDF 3548 Federal Register / Vol. 87, No. 15 / Monday, January 24, 2022 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-22–1308; Docket No. CDC–2022– 0007] 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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Validated Follow-up Interview of Clinicians on Outpatient Antibiotic Stewardship Interventions. This collection aims to perform an interview of outpatient clinicians regarding the acceptability and perceived clinician level barriers associated with our yearlong implementation of interventions designed around the Core Elements of Outpatient Antibiotic Stewardship. DATES: CDC must receive written comments on or before March 25, 2022. ADDRESSES: You may submit comments, identified by Docket No. CDC–2022– 0007 by any of the following methods: • Federal eRulemaking Portal: 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 SUMMARY: 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. change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (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; phone: 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 Proposed Project Validated Interview and Survey of Outpatient Providers on Antibiotic Stewardship Interventions (OMB Control No. 0920–1308)— Reinstatement—Division of Healthcare Quality Promotion (DHQP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Inappropriate antibiotic prescribing is a major driver of antibiotic resistance which is an urgent national and global health threat. Additionally, inappropriate antibiotic prescribing contributes to avoidable adverse drug events that cause substantial harm to patients. Most antibiotic prescribing originates in traditional outpatient settings such as physician offices and emergency departments and at least 30% of these prescriptions are completely unnecessary. Over the past decade there has been rapid growth in non-traditional outpatient settings including Urgent Care clinics. Recent evidence shows that when compared to traditional office settings, inappropriate antibiotic prescribing is substantially higher in Urgent Care clinics making this an important priority for antibiotic stewardship. The design, development, and evaluation of durable stewardship interventions addressing the unique setting of Urgent Care clinics is an important area of unmet need. This data will assess knowledge, attitudes, and practices related to antibiotic prescribing among clinicians after implementation of a year-long Urgent Care stewardship initiative. CDC requests approval for an estimated 62 annual burden hours. There is no cost to respondents other than their time. jspears on DSK121TN23PROD with NOTICES1 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Urgent Care Clinician ........................................ Urgent Care Clinician ........................................ Interview Guide ................................................. Survey ............................................................... 20 125 1 1 1 20/60 20 42 Total ............................................................ ........................................................................... ........................ ........................ ........................ 62 VerDate Sep<11>2014 18:11 Jan 21, 2022 Jkt 256001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\24JAN1.SGM 24JAN1 Federal Register / Vol. 87, No. 15 / Monday, January 24, 2022 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2022–01262 Filed 1–21–22; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Health Statistics (NCHS), ICD–10 Coordination and Maintenance (C&M) Committee Meeting Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: ACTION: Notice of virtual meeting. The CDC, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD–10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by audio lines available. Online Registration is not required. SUMMARY: The meeting will be held on March 8, 2022, from 9:00 a.m. to 5:00 p.m., EST, and March 9, 2022, from 9:00 a.m. to 5:00 p.m., EST. DATES: This is a virtual meeting. Information will be provided on each of our respective web pages when it becomes available. For CDC/NCHS https://www.cdc.gov/nchs/icd/icd10cm_ maintenance.htm. For CMS https:// www.cms.gov/Medicare/Coding/ ICD9ProviderDiagnosticCodes/meetings. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Traci Ramirez, Medical Systems Specialist, CDC, 3311 Toledo Road, Hyattsville, Maryland 20782, Telephone: (301) 458–4454; Email: TRamirez@cdc.gov. jspears on DSK121TN23PROD with NOTICES1 SUPPLEMENTARY INFORMATION: Purpose: The ICD–10 Coordination and Maintenance (C&M) Committee is a public forum for the presentation of proposed modifications to the International Classification of Diseases, Tenth Revision, Clinical Modification and ICD–10 Procedure Coding System. Matters To Be Considered: The tentative agenda will include discussions on ICD–10–CM and ICD– 10–PCS topics listed below. Agenda items are subject to change as priorities dictate. Please refer to the posted agenda for updates one month prior to the meeting. VerDate Sep<11>2014 18:11 Jan 21, 2022 Jkt 256001 ICD–10–PCS Topics 1. Administration of Spesolimab * 2. Administration of daratumumab and hyaluronidase-fihj * 3. Administration of Defencath * 4. Administration of Maribavir * 5. Administration of Teclistamab * 6. Administration of Mosunetuzumab * 7. Administration of afamitresgene autoleucel ** 8. Administration of tabelecleucel ** 9. Administration of Treosulfan * 10. Administration of inebilizumab-cdon * 11. Administration of Xenon-129 * 12. Administration of betibeglogene autotemcel ** 13. Administration of Omidubicel ** 14. Implantation of Sphenopalatine Ganglion Stimulator for Ischemic Stroke * 15. Gene Expression Assay ** 16. Vertebral Body Tethering * 17. Percutaneous Femoral-Popliteal Artery Bypass * 18. Computer-Assisted Transcranial Magnetic Stimulation * 19. Computer-Aided Analysis for the Detection and Classification of Epileptic Events * 20. Facet Replacement Spinal Stabilization Device * 21. Insertion of Sacropelvic Fixation System * 22. Insertion of an Implantable Vagus Nerve Stimulation System * 23. Insertion of a Paired Vagus Nerve Stimulation System * 24. Percutaneous Venous Thrombectomy for Postthrombotic Syndrome * 25. Quantitative Flow Ratio for Non-invasive Intraprocedural Analysis of Cardiac Angiography 26. Application of Allogeneic Thymus Derived Tissue 27. Supersaturated Oxygen Therapy 28. Assistance with Precision Stimulation Software * 29. Section X Updates 30. Addenda and Key Updates * Requestor has submitted a New Technology Add-on Payment (NTAP) application for FY 2023. ** Requestor intends to submit an NTAP application for FY 2024 consideration. Presentations for procedure code requests are conducted by both the requestor and CMS during the Coordination & Maintenance Committee meeting. Discussion from the requestor generally focuses on the clinical issues for the procedure or technology, followed by the proposed coding options from a CMS analyst. Topics presented may also include requests for new procedure codes that relate to a new technology add-on payment (NTAP) policy request. CMS is continuing to modify the approach for presenting the new technology add-on payment (NTAP) related ICD–10–PCS procedure code requests that involve the administration PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 3549 of a therapeutic agent for the March 8– 9, 2022 ICD–10 Coordination and Maintenance Committee meeting. Consistent with the requirements of section 1886(d)(5)(K)(iii) of the Social Security Act, applicants submitted requests to create a unique procedure code to describe the administration of a therapeutic agent, such as the option to create a new code in Section X within the ICD–10–PCS procedure code classification. CMS will initially only display those meeting materials associated with the NTAP related ICD– 10–PCS procedure code requests that involve the administration of a therapeutic agent on the CMS website in early February 2022 at: https:// www.cms.gov/Medicare/Coding/ICD10/ C-and-M-Meeting-Materials. The 13 NTAP related ICD–10–PCS procedure code requests that involve the administration of a therapeutic agent are: 1. Administration of Spesolimab * 2. Administration of daratumumab and hyaluronidase-fihj * 3. Administration of Defencath * 4. Administration of Maribavir * 5. Administration of Teclistamab * 6. Administration of Mosunetuzumab * 7. Administration of afamitresgene autoleucel ** 8. Administration of tabelecleucel ** 9. Administration of Treosulfan * 10. Administration of inebilizumab-cdon * 11. Administration of Xenon-129 * 12. Administration of betibeglogene autotemcel ** 13. Administration of Omidubicel ** These topics will not be presented during the March 8–9, 2022 meeting. CMS will solicit public comments regarding any clinical questions or coding options included for these 13 procedure code topics in advance of the meeting continuing through the end of the public comment period, April 8, 2022. Members of the public should send any questions or comments to the CMS mailbox at: ICDProcedure CodeRequest@cms.hhs.gov by the April 8, 2022 deadline. CMS intends to post a question and answer document in advance of the meeting to address any clinical or coding questions that members of the public may have submitted. Following the conclusion of the meeting, CMS will post an updated question and answer document to address any additional clinical or coding questions that members of the public may have submitted during the meeting that CMS was not able to address or that were submitted after the meeting. The NTAP related ICD–10–PCS procedure code requests that do not involve the administration of a E:\FR\FM\24JAN1.SGM 24JAN1

Agencies

[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Notices]
[Pages 3548-3549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01262]



[[Page 3548]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-1308; Docket No. CDC-2022-0007]


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 and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Validated Follow-up Interview of 
Clinicians on Outpatient Antibiotic Stewardship Interventions. This 
collection aims to perform an interview of outpatient clinicians 
regarding the acceptability and perceived clinician level barriers 
associated with our year-long implementation of interventions designed 
around the Core Elements of Outpatient Antibiotic Stewardship.

DATES: CDC must receive written comments on or before March 25, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0007 by any of the following methods:
     Federal eRulemaking Portal: 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 Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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; phone: 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

    Validated Interview and Survey of Outpatient Providers on 
Antibiotic Stewardship Interventions (OMB Control No. 0920-1308)--
Reinstatement--Division of Healthcare Quality Promotion (DHQP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Inappropriate antibiotic prescribing is a major driver of 
antibiotic resistance which is an urgent national and global health 
threat. Additionally, inappropriate antibiotic prescribing contributes 
to avoidable adverse drug events that cause substantial harm to 
patients. Most antibiotic prescribing originates in traditional 
outpatient settings such as physician offices and emergency departments 
and at least 30% of these prescriptions are completely unnecessary. 
Over the past decade there has been rapid growth in non-traditional 
outpatient settings including Urgent Care clinics. Recent evidence 
shows that when compared to traditional office settings, inappropriate 
antibiotic prescribing is substantially higher in Urgent Care clinics 
making this an important priority for antibiotic stewardship. The 
design, development, and evaluation of durable stewardship 
interventions addressing the unique setting of Urgent Care clinics is 
an important area of unmet need. This data will assess knowledge, 
attitudes, and practices related to antibiotic prescribing among 
clinicians after implementation of a year-long Urgent Care stewardship 
initiative.
    CDC requests approval for an estimated 62 annual burden hours. 
There is no cost to respondents other than their time.

                                        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)      (in hours)
----------------------------------------------------------------------------------------------------------------
Urgent Care Clinician.........  Interview Guide.              20               1               1              20
Urgent Care Clinician.........  Survey..........             125               1           20/60              42
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              62
----------------------------------------------------------------------------------------------------------------



[[Page 3549]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-01262 Filed 1-21-22; 8:45 am]
BILLING CODE 4163-18-P


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