National Committee on Vital and Health Statistics, 19597-19598 [2024-05779]

Download as PDF Federal Register / Vol. 89, No. 54 / Tuesday, March 19, 2024 / Notices information to national organizations included in The Union on all questions concerning scientific and sociological study on TB. The Union is uniquely qualified to combat TB and lung disease globally and to offer training and other capacity-building activities leading to health solutions for the poor in resource limited countries, the key activities under this NOFO, due to its WHOrecognized accomplishments and leadership role in the global TB fight since its founding in 1920. Summary of the Award Recipient: International Union Against Tuberculosis and Lung Disease (The Union). Purpose of the Award: The purpose of this award is to continue developing and updating TB scientific and programmatic resources, disseminating TB best practices, and building TB capacity. Amount of Award: For The Union, the approximate year 1 funding amount will be $500,000 in Federal Fiscal Year (FYY) 2024 funds, subject to the availability of funds. Funding amounts for years 2–5 will be set at continuation. Non-PEPFAR Authority: This program is authorized under section 307 of the Public Health Service Act (42 U.S.C. 242l), as amended and section 301(a) of the Public Health Service Act (42 U.S.C. 241(a)), as amended. Period of Performance: The period for this award will be September 30, 2024, through September 29, 2029. Dated: March 13, 2024. Jamie Legier, Acting Director, Office of Grants Services, Centers for Disease Control and Prevention. [FR Doc. 2024–05771 Filed 3–18–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1181] Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP AGENCY: Food and Drug Administration, ddrumheller on DSK120RN23PROD with NOTICES1 HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205864 and the new animal drug application (NADA) 141– 395 for the designated medical gas Helium, USP held by Air Products and SUMMARY: VerDate Sep<11>2014 19:45 Mar 18, 2024 Jkt 262001 Chemicals, Inc., 1940 Air Products Blvd., Allentown, PA 18106–5500 (Air Products). Air Products notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn. Approval is withdrawn as of April 18, 2024. DATES: 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; or Scott Fontana (HFV– 180), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240– 402–0656, Scott.Fontana@fda.hhs.gov. Air Products has informed FDA that it is no longer marketing the designated medical gas Helium, USP and has requested that FDA withdraw approval of NDA 205864 and NADA 141–395 under the processes in § 314.150© (21 CFR 314.150(c)) and § 514.115(d) (21 CFR 514.115(d)). Air Products has also, by its request, waived its opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) or an NADA or abbreviated new animal drug application under § 514.115(d) is without prejudice to refiling. Therefore, approval of NDA 205864 and NADA 141–395, and all amendments and supplements thereto, are hereby withdrawn as of April 18, 2024. Introduction or delivery for introduction into interstate commerce of Helium, USP, without an approved new drug application or an approved new animal drug application violates sections 505(a), 512(a), 301(a), and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a), 360b(a)(1), 331(a), and 331(d)). Any Helium, USP manufactured by Air Products pursuant to these applications that is in inventory on April 18, 2024 may continue to be dispensed until the inventories have been depleted or the drug product has reached its expiration date or otherwise become violative, whichever occurs first. SUPPLEMENTARY INFORMATION: Dated: March 13, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05742 Filed 3–18–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 19597 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics Centers for Disease Control and Prevention, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. The public is welcome to attend in person or to obtain the link to attend this meeting by following the instructions posted on the Committee website: https:// ncvhs.hhs.gov/meetings/full-committeemeeting-16/. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting. DATES: Thursday, April 11, 2024: 9:15 a.m.–5:30 p.m. EDT and Friday, April 12, 2024: 8:30 a.m.–3:00 p.m. EDT. ADDRESSES: In-person/hybrid (includes virtual attendance option). FOR MORE INFORMATION CONTACT: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, or via electronic mail to vgh4@ cdc.gov; or by telephone (301) 458– 4715. Summaries of meetings and a roster of Committee members are available on the NCVHS website https:// ncvhs.hhs.gov/, where further information including an agenda and instructions to access the broadcast of the meeting will be posted. Should you require reasonable accommodation, please telephone the CDC Office of Equal Employment Opportunity at (770) 488–3210 as soon as possible. SUPPLEMENTARY INFORMATION: Purpose: As outlined in its Charter, the National Committee on Vital and Health Statistics assists and advises the Secretary of HHS on health data, data standards, statistics, privacy, national health information policy, and the Department’s strategy to best address those issues. Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA),1 NCVHS advises the Secretary on administrative simplification standards, including those for privacy, security, SUMMARY: 1 Public Law 104–191, 110 Stat. 1936 (Aug 21, 1996), available at https://www.congress.gov/104/ plaws/publ191/PLAW-104publ191.pdf. E:\FR\FM\19MRN1.SGM 19MRN1 19598 Federal Register / Vol. 89, No. 54 / Tuesday, March 19, 2024 / Notices adoption and implementation of transaction standards, unique identifiers, code sets, and operating rules adopted under the Patient Protection and Affordable Care Act (ACA).2 The meeting agenda will include discussion of the 2024 workplan including the NCVHS Report to Congress, and briefings and discussions with invited experts on several health data policy topics, including: standards for SDOH data elements; possible implications of Value Based Care Models vs Fee-For-Service on HIPAA standards; an overview of the key elements of the Trusted Exchange Framework and Common Agreement (TEFCA) published by the Office of the National Coordinator for Health IT (ONC) in November 2023; and exploration of privacy and security in AI in technology and healthcare. The NCVHS Workgroup on Timely and Strategic Action to Inform ICD–11 Policy for morbidity will report to the full Committee on Phase II of its work focusing on analysis of the recent Request for Information (RFI), published in October 2023.3 The Committee will reserve time on the agenda for public comment. Meeting times and topics are subject to change. Please refer to the agenda posted on the NCVHS website for updates: https:// ncvhs.hhs.gov/meetings/full-committeemeeting-16/. Sharon Arnold, Associate Deputy Assistant Secretary, Office of Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2024–05779 Filed 3–18–24; 8:45 am] BILLING CODE 4150–05–P National Institutes of Health ddrumheller on DSK120RN23PROD with NOTICES1 National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 2 Public Law 111–148, 124 Stat.119, available at https://www.congress.gov/111/plaws/publ148/ PLAW-111publ148.pdf. 3 Federal Register Notice, October 16, 2023: https://www.federalregister.gov/documents/2023/ 10/16/2023-22753/national-committee-on-vitaland-health-statistics. 17:41 Mar 18, 2024 Jkt 262001 Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; P01 and R03 Review. Date: April 3, 2024. Time: 10:30 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852. Contact Person: M. Catherine Bennett, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH/HHS, NSC, 6001 Executive Blvd., Rockville, MD 20852, 301– 435–1766, bennettc3@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS). Dated: March 13, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–05727 Filed 3–18–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276– 1243. Comments are invited on: (a) whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Project: Minority AIDS Initiative— Management Reporting Tools (MAI– MRTs)—(OMB No. 0930–0357)— Renewal The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Prevention (CSAP) is requesting from the Office of Management and Budget (OMB) approval for the renewal of Minority AIDS Initiative (MAI) monitoring tools, which includes both youth and adult questionnaires, as well as the quarterly progress report. This revision includes the inclusion of new cohorts, substantial revisions to the youth and adult questionnaires, updates to the data used to estimate response rates and expected numbers of participants by service duration (see Table 1 below). The cohorts of grantees funded by the MAI and included in this clearance request are: • Prevention Navigators 2019 • Prevention Navigators 2020 • Prevention Navigators 2021 • Prevention Navigators 2022 • Prevention Navigators 2023 The target population for the grantees will be at-risk minority adolescents and young adults. All MAI grantees are expected to report their monitoring data using SAMHSA’s Strategic Prevention Framework (SPF) and to target minority populations, as well as other high-risk groups residing in communities of color with high prevalence of Substance Abuse and HIV/AIDS. The primary objectives of the monitoring tools include: • Assess the success of the MAI in reducing risk factors and increasing protective factors associated with the transmission of the Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and other sexually transmitted diseases (STD). • Measure the effectiveness of evidence-based programs and infrastructure development activities such as: outreach and training, mobilization of key stakeholders, substance abuse and HIV/AIDS counseling and education, testing, referrals to appropriate medical treatment and/or other intervention strategies (i.e., cultural enrichment E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 89, Number 54 (Tuesday, March 19, 2024)]
[Notices]
[Pages 19597-19598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Committee on Vital and Health Statistics

AGENCY: Centers for Disease Control and Prevention, Department of 
Health and Human Services.

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, the Department 
of Health and Human Services (HHS) announces the following advisory 
committee meeting. This meeting is open to the public. The public is 
welcome to attend in person or to obtain the link to attend this 
meeting by following the instructions posted on the Committee website: 
https://ncvhs.hhs.gov/meetings/full-committee-meeting-16/.
    Name: National Committee on Vital and Health Statistics (NCVHS) 
Meeting.

DATES: Thursday, April 11, 2024: 9:15 a.m.-5:30 p.m. EDT and Friday, 
April 12, 2024: 8:30 a.m.-3:00 p.m. EDT.

ADDRESSES: In-person/hybrid (includes virtual attendance option).

FOR MORE INFORMATION CONTACT: Substantive program information may be 
obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National 
Center for Health Statistics, Centers for Disease Control and 
Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, or via 
electronic mail to [email protected]; or by telephone (301) 458-4715. 
Summaries of meetings and a roster of Committee members are available 
on the NCVHS website https://ncvhs.hhs.gov/, where further information 
including an agenda and instructions to access the broadcast of the 
meeting will be posted.
    Should you require reasonable accommodation, please telephone the 
CDC Office of Equal Employment Opportunity at (770) 488-3210 as soon as 
possible.

SUPPLEMENTARY INFORMATION: 
    Purpose: As outlined in its Charter, the National Committee on 
Vital and Health Statistics assists and advises the Secretary of HHS on 
health data, data standards, statistics, privacy, national health 
information policy, and the Department's strategy to best address those 
issues. Under the Health Insurance Portability and Accountability Act 
of 1996 (HIPAA),\1\ NCVHS advises the Secretary on administrative 
simplification standards, including those for privacy, security,

[[Page 19598]]

adoption and implementation of transaction standards, unique 
identifiers, code sets, and operating rules adopted under the Patient 
Protection and Affordable Care Act (ACA).\2\
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    \1\ Public Law 104-191, 110 Stat. 1936 (Aug 21, 1996), available 
at https://www.congress.gov/104/plaws/publ191/PLAW-104publ191.pdf.
    \2\ Public Law 111-148, 124 Stat.119, available at https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf.
---------------------------------------------------------------------------

    The meeting agenda will include discussion of the 2024 workplan 
including the NCVHS Report to Congress, and briefings and discussions 
with invited experts on several health data policy topics, including: 
standards for SDOH data elements; possible implications of Value Based 
Care Models vs Fee-For-Service on HIPAA standards; an overview of the 
key elements of the Trusted Exchange Framework and Common Agreement 
(TEFCA) published by the Office of the National Coordinator for Health 
IT (ONC) in November 2023; and exploration of privacy and security in 
AI in technology and healthcare.
    The NCVHS Workgroup on Timely and Strategic Action to Inform ICD-11 
Policy for morbidity will report to the full Committee on Phase II of 
its work focusing on analysis of the recent Request for Information 
(RFI), published in October 2023.\3\
---------------------------------------------------------------------------

    \3\ Federal Register Notice, October 16, 2023: https://www.federalregister.gov/documents/2023/10/16/2023-22753/national-committee-on-vital-and-health-statistics.
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    The Committee will reserve time on the agenda for public comment. 
Meeting times and topics are subject to change. Please refer to the 
agenda posted on the NCVHS website for updates: https://ncvhs.hhs.gov/meetings/full-committee-meeting-16/.

Sharon Arnold,
Associate Deputy Assistant Secretary, Office of Science and Data 
Policy, Office of the Assistant Secretary for Planning and Evaluation.
[FR Doc. 2024-05779 Filed 3-18-24; 8:45 am]
BILLING CODE 4150-05-P
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