Agency Information Collection Activities: Proposed Collection; Comment Request, 26551-26552 [2023-09142]

Download as PDF Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2023–09088 Filed 4–28–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC). The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. DATES: Nominations for membership on the HICPAC must be received no later than September 29, 2023. Packages received after this time will not be considered for the current membership cycle. ADDRESSES: All nominations should be emailed to HICPAC, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC, l600 Clifton Road NE, Mailstop H16–3, Atlanta, Georgia 30329, emailed (recommended) to hicpac@cdc.gov, or faxed to (404) 639–4043. FOR FURTHER INFORMATION CONTACT: Sydnee Byrd, MPA, Healthcare Infection Control Practices Advisory Committee, Division of Healthcare Quality Promotion, NCEZID, Centers for Disease Control and Prevention, l600 Clifton Road NE, Mailstop H16–3, Atlanta, Georgia 30329–4027. Telephone (404) 718–8039; Email: hicpac@cdc.gov. SUPPLEMENTARY INFORMATION: The Healthcare Infection Control Practices Advisory Committee shall provide advice and guidance to the Secretary, Department of Health and Human lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 Services (HHS); the Director, Centers for Disease Control and Prevention (CDC); the Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), CDC; and the Director, Division of Healthcare Quality Promotion (DHQP), NCEZID, CDC; and the Director, Division of Healthcare Quality Promotion (DHQP), NCEZID, CDC, regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcareassociated infections antimicrobial resistance and related events in settings where healthcare is provided, including hospitals, outpatient settings, long-term care facilities, and home health agencies. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee’s objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of HICPAC objectives. HHS policy stipulates that committee membership be balanced in terms of points of view represented, and the committee’s function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning of and annually during their terms. CDC reviews potential candidates for HICPAC membership each year and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in July 2023, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 26551 in one year may be reconsidered in a subsequent year. Candidates should submit the following items: D Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address). D At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.). Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2023–09067 Filed 4–28–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10717] 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 (the 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 SUMMARY: E:\FR\FM\01MYN1.SGM 01MYN1 26552 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 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 information technology to minimize the information collection burden. DATES: Comments must be received by June 30, 2023. 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:__, 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). CMS–10717 Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols 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 VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 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 Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Program Audit and IndustryWide Part C Timeliness Monitoring Project (TMP) Protocols; Use: Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and implementing regulations at 42 CFR parts 422 and 423, Medicare Part D plan sponsors and Medicare Advantage organizations are required to comply with all Medicare Parts C and D program requirements. CMS’ annual audit plan ensures that we evaluate sponsoring organizations’ compliance with these requirements by conducting program audits that focus on high-risk areas that have the greatest potential for beneficiary harm. As such, CMS has developed the following audit protocols for use by sponsoring organizations to prepare for their audit: • Compliance Program Effectiveness (CPE) • Part D Formulary and Benefit Administration (FA) • Part D Coverage Determinations, Appeals, and Grievances (CDAG) • Part C Organization Determinations, Appeals, and Grievances (ODAG) • Special Needs Plans Care Coordination (SNPCC) CMS generally conducts program audits at the parent organization level in an effort to reduce burden and, for routine audits, subjects each sponsoring organization to all applicable program area protocols. For example, if a sponsoring organization does not offer a special needs plan, or an accrediting organization has deemed a special needs plan compliant with CMS regulations and standards, CMS would not apply the SNPCC protocol. Likewise, CMS would not apply the ODAG audit protocol to an organization that offers PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 only a standalone prescription drug plan since that organization does not offer the MA benefit. Conversely, ad hoc audits resulting from referral may be limited in scope and, therefore, all program area protocols may not be applied. The information gathered during this program audit will be used by the Medicare Parts C and D Oversight and Enforcement Group (MOEG) within the Center for Medicare (CM) and CMS Regional Offices to assess sponsoring organizations’ compliance with Medicare program requirements. If outliers or other data anomalies are detected, Regional Offices will work in collaboration with MOEG and other divisions within CMS for follow-up and resolution. Additionally, MA and Part D organizations will receive the audit results and will be required to implement corrective action to correct any identified deficiencies. Form Number: CMS–10717 (OMB control number: 0938–1395); Frequency: Yearly; Affected Public: Private Sector, State, Local, or Tribal Governments, Federal Government, Business or other forprofits, Not-for-Profit Institutions; Number of Respondents: 182; Total Annual Responses: 182; Total Annual Hours: 36,444. (For policy questions regarding this collection contact Matthew Guerand at 303–844–7120.) Dated: April 26, 2022. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. Editorial Note: This document arrived at the Office of the Federal Register on April 26, 2023. [FR Doc. 2023–09142 Filed 4–28–23; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–0081] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the SUMMARY: E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26551-26552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10717]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 (the 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

[[Page 26552]]

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 information technology to minimize the 
information collection burden.

DATES: Comments must be received by June 30, 2023.

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:__, 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/PRA-Listing.

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).
CMS-10717 Medicare Part C and Part D Program Audit and Industry-Wide 
Part C Timeliness Monitoring Project (TMP) Protocols
    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 Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Part C 
and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring 
Project (TMP) Protocols; Use: Under the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 and implementing regulations 
at 42 CFR parts 422 and 423, Medicare Part D plan sponsors and Medicare 
Advantage organizations are required to comply with all Medicare Parts 
C and D program requirements. CMS' annual audit plan ensures that we 
evaluate sponsoring organizations' compliance with these requirements 
by conducting program audits that focus on high-risk areas that have 
the greatest potential for beneficiary harm. As such, CMS has developed 
the following audit protocols for use by sponsoring organizations to 
prepare for their audit:

 Compliance Program Effectiveness (CPE)
 Part D Formulary and Benefit Administration (FA)
 Part D Coverage Determinations, Appeals, and Grievances (CDAG)
 Part C Organization Determinations, Appeals, and Grievances 
(ODAG)
 Special Needs Plans Care Coordination (SNPCC)

    CMS generally conducts program audits at the parent organization 
level in an effort to reduce burden and, for routine audits, subjects 
each sponsoring organization to all applicable program area protocols. 
For example, if a sponsoring organization does not offer a special 
needs plan, or an accrediting organization has deemed a special needs 
plan compliant with CMS regulations and standards, CMS would not apply 
the SNPCC protocol. Likewise, CMS would not apply the ODAG audit 
protocol to an organization that offers only a standalone prescription 
drug plan since that organization does not offer the MA benefit. 
Conversely, ad hoc audits resulting from referral may be limited in 
scope and, therefore, all program area protocols may not be applied.
    The information gathered during this program audit will be used by 
the Medicare Parts C and D Oversight and Enforcement Group (MOEG) 
within the Center for Medicare (CM) and CMS Regional Offices to assess 
sponsoring organizations' compliance with Medicare program 
requirements. If outliers or other data anomalies are detected, 
Regional Offices will work in collaboration with MOEG and other 
divisions within CMS for follow-up and resolution. Additionally, MA and 
Part D organizations will receive the audit results and will be 
required to implement corrective action to correct any identified 
deficiencies. Form Number: CMS-10717 (OMB control number: 0938-1395); 
Frequency: Yearly; Affected Public: Private Sector, State, Local, or 
Tribal Governments, Federal Government, Business or other for-profits, 
Not-for-Profit Institutions; Number of Respondents: 182; Total Annual 
Responses: 182; Total Annual Hours: 36,444. (For policy questions 
regarding this collection contact Matthew Guerand at 303-844-7120.)

    Dated: April 26, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.

    Editorial Note: This document arrived at the Office of the 
Federal Register on April 26, 2023.
[FR Doc. 2023-09142 Filed 4-28-23; 8:45 am]
BILLING CODE P
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