Agency Information Collection Activities: Submission for OMB Review; Comment Request, 71367-71368 [2023-22791]

Download as PDF Federal Register / Vol. 88, No. 198 / Monday, October 16, 2023 / Notices Respondent Form Number of respondents Number of responses per respondent Average burden per response (in hours) Non-responding SSPs ................................... Non-Response Survey Item .......................... 1000 1 2/60 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. 2023–22777 Filed 10–13–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10241 and CMS– 10717] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by November 15, 2023. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent SUMMARY: VerDate Sep<11>2014 17:03 Oct 13, 2023 Jkt 262001 within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. 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: AGENCY: ddrumheller on DSK120RN23PROD with NOTICES1 71367 William Parham at (410) 786–4669. 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. 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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Survey of Retail Prices; Use: This information collection request provides for a survey of the average acquisition costs of all covered outpatient drugs purchased by retail community pharmacies. CMS may contract with a vendor to conduct monthly surveys of retail prices for covered outpatient drugs. Such prices represent a nationwide average of consumer purchase prices, net of discounts and rebates. The contractor SUPPLEMENTARY INFORMATION: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 shall provide notification when a drug product becomes generally available and that the contract includes such terms and conditions as the Secretary shall specify, including a requirement that the vendor monitor the marketplace. CMS has developed a National Average Drug Acquisition Cost (NADAC) for states to consider when developing reimbursement methodology. The NADAC is a pricing benchmark that is based on the national average costs that pharmacies pay to acquire Medicaid covered outpatient drugs. This pricing benchmark is based on drug acquisition costs collected directly from pharmacies through a nationwide survey process. This survey is conducted on a monthly basis to ensure that the NADAC reference file remains current and up-to-date. Form Number: CMS–10241 (OMB control number 0938–1041); Frequency: Monthly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 72,000; Total Annual Responses: 72,000; Total Annual Hours: 36,000. (For policy questions regarding this collection contact: Robert Giles at 667–290–8626.) 2. 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) E:\FR\FM\16OCN1.SGM 16OCN1 71368 Federal Register / Vol. 88, No. 198 / Monday, October 16, 2023 / Notices • Part C Organization Determinations, Appeals, and Grievances (ODAG) • Special Needs Plans Care Coordination (SNPCC) ddrumheller on DSK120RN23PROD with NOTICES1 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 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: October 11, 2023. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2023–22791 Filed 10–13–23; 8:45 am] BILLING CODE 4120–01–P VerDate Sep<11>2014 17:03 Oct 13, 2023 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Fiscal Year 2023 Health Center Program COVID–19 HHS Bridge Access Program Funding Awards Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of funding awards. submit data on program activities through the HRSA Health Center COVID–19 survey as required, as well as periodic progress reports. Carole Johnson, Administrator. [FR Doc. 2023–22751 Filed 10–13–23; 8:45 am] BILLING CODE 4165–15–P AGENCY: In support of the HHS Bridge Access Program for COVID–19 Vaccines and Treatments, HRSA provided more than $81 million in one-time funding to all current Health Center Program operational (H80) award recipients and to health center look-alikes that previously received American Rescue Plan funding (L2C awards). FOR FURTHER INFORMATION CONTACT: Olivia Shockey, Expansion Division Director, HRSA, at oshockey@hrsa.gov and (301) 594–4300. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: The total amount of funding, number of awards, and award recipients can be found here: https://bphc.hrsa.gov/ funding/coronavirus-related-funding/ covid-19-bridge-funding/fy-2023awards. Project Period: September 1, 2023— December 31, 2024. CFDA Number: 93.527. Authority: Section 2401 of the American Rescue Plan Act of 2021, Public Law 117–2. Justification: The end of the declared COVID–19 Public Health Emergency and associated transition to commercial access to vaccines and therapeutics impacts the capacity of health centers to maintain essential COVID–19 related services for their patients, including but not limited to health center patients who lack health insurance. Health centers will use one-time Bridge funding to support uninsured and underinsured patients and residents of their communities with needs such as COVID–19 vaccination and therapeutics, enabling/patient support services (such as outreach, education, enrollment assistance, transportation, translation, and care coordination) to support COVID–19 related services; community COVID–19 vaccination events; and, supplies and personnel who support COVID–19 related services and care delivery, including personnel costs necessary to develop, support, or expand collaborations, including collaborations with state/jurisdiction immunization programs. Recipients will SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Advisory Council on Alzheimer’s Research, Care, and Services; Meeting Assistant Secretary for Planning and Evaluation, HHS. ACTION: Notice of meeting. AGENCY: This notice announces the public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias (ADRD) on people with the disease and their caregivers. During the meeting on October 30, 2023, the Advisory Council will welcome a new cohort of members and hear updates from federal agencies on key activities over the last quarter. A panel will present information on interventions to reduce the risk of developing dementia. DATES: The meeting will be held virtually on October 30 from 12 p.m. to 4:30 p.m. EDT. ADDRESSES: The meeting will be virtual. It will stream live at www.hhs.gov/live. Comments: Time is allocated on the agenda to hear public comments from 4 p.m. to 4:30 p.m. The time for oral comments will be limited to two (2) minutes per individual. In order to provide a public comment, please register by emailing your name to napa@hhs.gov by Thursday, October 26. Registered commenters will receive both a dial-in number and a link to join the meeting virtually; individuals will have the choice to either join virtually via the link, or to call in only by using the dialin number. Note: There may be a 30–45 second delay in the livestream video presentation of the conference. For this reason, if you have pre-registered to submit a public comment, it is important to connect to the meeting by 3:45 p.m. to ensure that you do not miss your name and allotted time when called. If you miss your name and allotted time to speak, you may not be able to make your public comment. All participant audio lines will be muted for the duration of the meeting and only unmuted by the Host at the time of the SUMMARY: E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 88, Number 198 (Monday, October 16, 2023)]
[Notices]
[Pages 71367-71368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10241 and CMS-10717]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by November 15, 2023.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 Parham at (410) 786-4669.

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. 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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Survey of Retail 
Prices; Use: This information collection request provides for a survey 
of the average acquisition costs of all covered outpatient drugs 
purchased by retail community pharmacies. CMS may contract with a 
vendor to conduct monthly surveys of retail prices for covered 
outpatient drugs. Such prices represent a nationwide average of 
consumer purchase prices, net of discounts and rebates. The contractor 
shall provide notification when a drug product becomes generally 
available and that the contract includes such terms and conditions as 
the Secretary shall specify, including a requirement that the vendor 
monitor the marketplace. CMS has developed a National Average Drug 
Acquisition Cost (NADAC) for states to consider when developing 
reimbursement methodology. The NADAC is a pricing benchmark that is 
based on the national average costs that pharmacies pay to acquire 
Medicaid covered outpatient drugs. This pricing benchmark is based on 
drug acquisition costs collected directly from pharmacies through a 
nationwide survey process. This survey is conducted on a monthly basis 
to ensure that the NADAC reference file remains current and up-to-date. 
Form Number: CMS-10241 (OMB control number 0938-1041); Frequency: 
Monthly; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 72,000; Total Annual Responses: 
72,000; Total Annual Hours: 36,000. (For policy questions regarding 
this collection contact: Robert Giles at 667-290-8626.)
    2. 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)

[[Page 71368]]

 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: October 11, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-22791 Filed 10-13-23; 8:45 am]
BILLING CODE 4120-01-P
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