Agency Information Collection Activities: Proposed Collection; Comment Request, 50157-50158 [2023-16281]

Download as PDF 50157 Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Form name Employees and Representatives .......... Health Hazard Evaluation Request Form. Health Hazard Evaluation Request Form. Health Hazard Evaluation specific interview example. Health Hazard Evaluation specific questionnaire example. HHE specific informed consent form ... Contact information post card .............. First Followback Survey ....................... Employers ............................................. Employees ............................................ Employees ............................................ Employees ............................................ Employees ............................................ Employees and Representatives; Employers—Year 1 (on-site evaluation). Employees and Representatives; Employers—Year 1 (on-site evaluation). Employees and Representatives; Employers—Year 2 (on-site evaluation). Employees and Representatives; Employers—Year 1 (without on-site evaluation). Employees and Representatives; Employers—Year 2 (without on-site evaluation). Total ............................................... 35 75 1 12/60 15 1,470 1 15/60 368 2,100 1 30/60 1,050 60 1,225 140 1 1 1 30/60 5/60 10/60 30 102 23 Second Followback Survey .................. 140 1 20/60 47 Third Followback Survey ...................... 140 1 15/60 35 First Followback Survey ....................... 94 1 10/60 16 Second Followback Survey .................. 94 1 15/60 24 ............................................................... ........................ ........................ .................... 1,745 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10241] 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 18:34 Jul 31, 2023 Jkt 259001 Total burden (in hours) 12/60 BILLING CODE 4163–18–P VerDate Sep<11>2014 Average burden per response (in hours) 1 [FR Doc. 2023–16221 Filed 7–31–23; 8:45 am] SUMMARY: Number of responses per respondent 175 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. lotter on DSK11XQN23PROD with NOTICES1 Number of respondents Type of respondents 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 October 2, 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. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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–10241 Survey of Retail Prices 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 E:\FR\FM\01AUN1.SGM 01AUN1 50158 Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices 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 lotter on DSK11XQN23PROD with NOTICES1 Dated: July 27, 2023. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2023–16281 Filed 7–31–23; 8:45 am] BILLING CODE 4120–01–P 18:34 Jul 31, 2023 Centers for Medicare & Medicaid Services Statement of Organization, Functions, and Delegations of Authority Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: 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.) VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 259001 The Centers for Medicare and Medicaid Services, Center for Medicare and Medicaid Innovation (CMMI), has modified its organizational structure. DATES: These new organizational structures were approved by the Secretary of Health and Human Services and took effect on July 27, 2023. FOR FURTHER INFORMATION CONTACT: Joe Kane at (410) 786–0655; 7500 Security Blvd., Baltimore, MD. SUPPLEMENTARY INFORMATION: Part F of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) (last amended at Federal Register, Vol. 88, No. 107, pp. 36586–36587, dated June 5, 2023) is further amended to reflect the establishment of the Division of Drug Innovation within the Center for Medicare and Medicaid Innovation (CMMI). Part F, Section FC. 10 (Organization) is revised as follows: Center for Medicare and Medicaid Innovation (CMMI), Seamless Care Models Group, Seamless Care Models Group, Division of Health Plan Innovations SUMMARY: Part F, Section FC. 20 (Functions) for the new organization is as follows: Centers for Medicare & Medicaid Services Office of the Administrator Center for Medicare and Medicaid Innovation Seamless Care Models Group Division of Drug Innovation • Directs, designs and implements models to test alternative approaches to payment for drugs in Medicare Part B, Part D, and Medicaid to optimize access to high quality, affordable drugs. • Seeks and develop opportunities to include Part B and Part D drugs in alternative payment models, including accountable care models, and addresses regulatory and operational issues that arise when trying to develop a model crossing different parts of the Medicare program. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 • Builds relationships within CMS and HHS, with States and Medicaid agencies, and with both governmental and non-governmental entities to develop, implement, and operate innovative Medicare Part B, Part D, and Medicaid models. • Meets with model participants and other interested parties, including relevant Government officials, representatives from the pharmaceutical industry, payers, providers, academia, and consumer advocates regarding their perspectives on innovative models, research, and ideas for new models. • Conducts formative research studies to inform innovative payment models. • Provides technical expertise to various CMS and non-Governmental entities on innovative Medicare Part B, Part D, and Medicaid payment and service delivery models to optimize access to affordable drugs. Authority: 44 U.S.C. 3101. Xavier Becerra, Secretary of Health and Human Services. [FR Doc. 2023–16280 Filed 7–31–23; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–P–1574] Determination That Progesterone Injection, USP, 50 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that Progesterone Injection, USP, 50 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Iris Masucci, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993–0002, 301–796–3600, Iris.Masucci@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and SUMMARY: E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50157-50158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16281]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10241]


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 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 October 2, 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-10241 Survey of Retail Prices
    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

[[Page 50158]]

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: 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.)

    Dated: July 27, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-16281 Filed 7-31-23; 8:45 am]
BILLING CODE 4120-01-P
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