Agency Information Collection Request; 60-Day Public Comment Request, 87788-87789 [2023-27868]

Download as PDF 87788 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices document announced the withdrawal of approval of 103 new drug applications and 35 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 13, 2009. The document erroneously included ANDA 75–108. The correct ANDA is ANDA 76–108 for Amiodarone hydrochloride (HCl) injection, 50 milligrams (mg)/milliliter (mL), held by Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045–5046. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137, Kimberly.Lehrfeld@ fda.hhs.gov. In the Federal Register of February 11, 2009 (74 FR 6896), appearing on page 6900 in FR Doc. E9–2901, the following correction is made: On page 6900, in the table, in the first column, the Application No. for the entry for Amiodarone HCL Injection, 50 mg/mL held by Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045–5046 is corrected to ANDA 76–108. SUPPLEMENTARY INFORMATION: Dated: December 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–27859 Filed 12–18–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0955–0019] Agency Information Collection Request; 60-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health SUMMARY: and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before February 20, 2024. ADDRESSES: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 264–0041 and PRA@HHS.GOV. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0955–0019 and project title for reference, to Sherrette A. Funn, email: Sherrette.Funn@hhs.gov, PRA@HHS.GOV or call (202) 264–0041 the Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: National Survey of Health Information Exchange Organizations (HIO). Type of Collection: Revision of a previously approved collection. OMB No.: 0955–0019. Abstract: Under the Department of Health and Human Services, Office of National Coordinator for Health Information and Technology, Electronic health information exchange (HIE) was one of three goals specified by Congress in the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act to ensure that the $30 billion federal investment in certified electronic health records (EHRs) resulted in higher-quality, lowercost care. Subsequent legislation and regulations have continued to prioritize the sharing of data electronically across EHRs and other health information systems. Health information exchange organizations (HIOs) play a pivotal role facilitating health information exchange across disparate providers, labs, pharmacies, public health departments, and others. This information collection request will gather data from HIOs across the nation through the administration of a survey of HIOs to generate the most current national statistics and associated actionable insights to inform policy efforts. The timely collection of national data from our survey will assess current capabilities of HIOs to support effective electronic information sharing within the U.S. healthcare system. Since prior to HITECH there has been ongoing assessment of trends in the capabilities of HIOs to support clinical exchange through nationwide surveys of HIOs. These prior surveys and studies have collected data on organizational structure, financial viability, geographic coverage, scope of services, scope of participants, perceptions of information blocking, support for public health exchange, and participation in national networks and the Technical Exchange Framework and Common Agreement (TEFCA). Continuing the ongoing data collection will be useful to construct a current and comprehensive picture of HIOs’ role in facilitating exchange and ensuring rapid access to important health care data and information when it matters most, including vital data to address public health emergencies. The survey will collect data on HIO capabilities to support electronic health information exchange, their maturity, and challenges they face. There are five key areas that require assessment: (1) adoption of technical standards; (2) perceptions related to information blocking; (3) HIE coordination at the federal level; (4) public health data exchange; and (5) organizational demographics, including technical capabilities offered by HIOs and the challenges they face in supporting electronic health information exchange. This is a 3-year request for OMB approval. ANNUALIZED BURDEN HOUR TABLE lotter on DSK11XQN23PROD with NOTICES1 Forms (if necessary) Total ............................ VerDate Sep<11>2014 Respondents (if necessary) Number of respondents Number of responses per respondents Average burden per response Total burden hours U.S. based public and private HIOs ............... 100 1 45/60 75 ......................................................................... ........................ 1 ........................ 75 17:33 Dec 18, 2023 Jkt 262001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2023–27868 Filed 12–18–23; 8:45 am] BILLING CODE 4150–45–P Outpatient per Visit Rate (Excluding Medicare) Calendar Year 2024 Lower 48 States: $719. Alaska: $1,060. Outpatient per Visit Rate (Medicare) DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Calendar Year 2024 Lower 48 States: $667. Alaska: $961. RIN 0917–AA23 Medicare Part B Inpatient Ancillary Per Diem Rate Calendar Year 2024 Lower 48 States: $963. Alaska: $1,341. Reimbursement Rates for Calendar Year 2024 AGENCY: ACTION: Indian Health Service, HHS. Outpatient Surgery Rate (Medicare) Established Medicare rates for freestanding Ambulatory Surgery Centers. Notice. Notice is provided that the Director of the Indian Health Service (IHS) has approved the rates for inpatient and outpatient medical care provided by the IHS facilities for Calendar Year 2024. SUMMARY: SUPPLEMENTARY INFORMATION: Background lotter on DSK11XQN23PROD with NOTICES1 The Director of the Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83–568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2024 for Medicare and Medicaid beneficiaries, beneficiaries of other federal programs, and for recoveries under the Federal Medical Care Recovery Act (42 U.S.C. 2651– 2653). The inpatient rates for Medicare Part A are excluded from the table below. That is because Medicare inpatient payments for IHS hospital facilities are made based on the prospective payment system, or (when IHS facilities are designated as Medicare Critical Access Hospitals) on a reasonable cost basis. Since the inpatient per diem rates set forth below do not include all physician services and practitioner services, additional payment shall be available to the extent that those services are provided. Inpatient Hospital Per Diem Rate (Excludes Physician/Practitioner Services) Calendar Year 2024 Lower 48 States: $5,083. Alaska: $4,326. VerDate Sep<11>2014 17:33 Dec 18, 2023 Jkt 262001 Effective Date for Calendar Year 2024 Rates Consistent with previous annual rate revisions, the Calendar Year 2024 rates will be effective for services provided on or after January 1, 2024, to the extent consistent with payment authorities, including the applicable Medicaid State plan. Roselyn Tso, Director, Indian Health Service. [FR Doc. 2023–27815 Filed 12–18–23; 8:45 am] BILLING CODE 4166–14–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket Number: USCG–2023–0922] Designation of the New England Commission of Higher Education as a Designated Entity and Appointment of Dr. Amy Donahue as a Member of the Commission Coast Guard, Department of Homeland Security (DHS). ACTION: Notice. AGENCY: The Coast Guard announces the designation of the New England Commission of Higher Education (NECHE) as a designated non-federal entity for the purposes of participation in its management by an authorized Coast Guard employee. Dr. Amy Donahue, the Provost of the Coast Guard Academy, has been authorizated to serve as a member of NECHE to provide oversight of, advice to, and coordination with, NECHE. Dr. Donahue will not participate in the day-to-day operations of NECHE. SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 87789 The designation and authorization are effective on November 21, 2023. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2023– 0922 in the search box and click ‘‘Search.’’ Next, in the Document Type column, select ‘‘Supporting & Related Material.’’ FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call or email Comamnder Jeffrey G. Janaro, Coast Guard Academy, telephone 860– 444–8255, email jeff.g.janaro@uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard announces the designation of the New England Commission of Higher Education (NECHE) as a ‘‘designated entity’’ under 10 U.S.C. 1589 and 1033. The Coast Guard also announces the participation of the Coast Guard Academy Provost Dr. Amy Donhue in the management of the entity as a Commisioner. Sections 1589 and 1033 allow the Secretary of the Department of Homeland Security to specify certain non-federal entities as ‘‘designated entities’’ in which a member of the armed forces or a civilian employee may be authorized to participate in a specific capacity. The Secretary delegated this authority to the Commandant of the Coast Guard through the Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3 (paragraph II.14). A ‘‘designated entity’’ must meet the requirements of 10 U.S.C. 1033. In relevant part, section 1033 requires an entity to be a non-profit oganization and perform one of the statutorily enumerated functions, including accreditation of service academies and other schools of the armed forces. NECHE is a voluntary non-government association that provides accreditation to the U.S. Coast Guard Academy. Therefore, NECHE is an entity that may be designated under 10 U.S.C. 1033 and, in turn, 10 U.S.C. 1589. Section 1589 also allows the Secretary concerned to authorize an employee, including a civilian officer, to participate, without compensation, in the managemenent of a designated entity for the purposes of oversight, advice to, and coordination with that designated entity. An employee’s participation may not extend to the day to day operations of the entity. The Coast Guard Academy announces the authorization of Dr. Amy Donahue, the Provost of the Coast Guard Academy, to participate in the management of NECHE within limits of 10 U.S.C. 1033 and 10 U.S.C. 1589. Specifically, and in DATES: E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87788-87789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27868]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0955-0019]


Agency Information Collection Request; 60-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before February 20, 
2024.

ADDRESSES: Submit your comments to [email protected] or by calling 
(202) 264-0041 and [email protected].

FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting 
information, please include the document identifier 0955-0019 and 
project title for reference, to Sherrette A. Funn, email: 
[email protected], [email protected] or call (202) 264-0041 the Reports 
Clearance Officer.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    Title of the Collection: National Survey of Health Information 
Exchange Organizations (HIO).
    Type of Collection: Revision of a previously approved collection.
    OMB No.: 0955-0019.
    Abstract: Under the Department of Health and Human Services, Office 
of National Coordinator for Health Information and Technology, 
Electronic health information exchange (HIE) was one of three goals 
specified by Congress in the 2009 Health Information Technology for 
Economic and Clinical Health (HITECH) Act to ensure that the $30 
billion federal investment in certified electronic health records 
(EHRs) resulted in higher-quality, lower-cost care. Subsequent 
legislation and regulations have continued to prioritize the sharing of 
data electronically across EHRs and other health information systems. 
Health information exchange organizations (HIOs) play a pivotal role 
facilitating health information exchange across disparate providers, 
labs, pharmacies, public health departments, and others. This 
information collection request will gather data from HIOs across the 
nation through the administration of a survey of HIOs to generate the 
most current national statistics and associated actionable insights to 
inform policy efforts. The timely collection of national data from our 
survey will assess current capabilities of HIOs to support effective 
electronic information sharing within the U.S. healthcare system.
    Since prior to HITECH there has been ongoing assessment of trends 
in the capabilities of HIOs to support clinical exchange through 
nationwide surveys of HIOs. These prior surveys and studies have 
collected data on organizational structure, financial viability, 
geographic coverage, scope of services, scope of participants, 
perceptions of information blocking, support for public health 
exchange, and participation in national networks and the Technical 
Exchange Framework and Common Agreement (TEFCA). Continuing the ongoing 
data collection will be useful to construct a current and comprehensive 
picture of HIOs' role in facilitating exchange and ensuring rapid 
access to important health care data and information when it matters 
most, including vital data to address public health emergencies.
    The survey will collect data on HIO capabilities to support 
electronic health information exchange, their maturity, and challenges 
they face. There are five key areas that require assessment: (1) 
adoption of technical standards; (2) perceptions related to information 
blocking; (3) HIE coordination at the federal level; (4) public health 
data exchange; and (5) organizational demographics, including technical 
capabilities offered by HIOs and the challenges they face in supporting 
electronic health information exchange.
    This is a 3-year request for OMB approval.

                                          Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
     Forms (if necessary)       Respondents  (if     Number of     responses per    burden per     Total burden
                                   necessary)       respondents     respondents      response          hours
----------------------------------------------------------------------------------------------------------------
                                U.S. based                   100               1           45/60              75
                                 public and
                                 private HIOs.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............               1  ..............              75
----------------------------------------------------------------------------------------------------------------



[[Page 87789]]

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2023-27868 Filed 12-18-23; 8:45 am]
BILLING CODE 4150-45-P


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