Meeting of the Advisory Committee on Blood and Tissue Safety and Availability, 60404-60405 [2022-21620]

Download as PDF 60404 Federal Register / Vol. 87, No. 192 / Wednesday, October 5, 2022 / Notices jspears on DSK121TN23PROD with NOTICES CMS–10260—Medicare Advantage and Prescription Drug Program: Final Marketing Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3). CMS–10142—Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP). 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: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage and Prescription Drug Program: Final Marketing Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3); Use: CMS requires MA organizations and Part D sponsors to use the standardized documents being submitted for OMB approval to satisfy disclosure requirements mandated by section 1851 (d)(3)(A) of the Act and § 422.111 for MA organizations and section 1860D–1(c) of the Act and § 423.128(a)(3) for Part D sponsors. The regulatory provisions at §§ 422.111(b) and 423.128(b) require MA organizations and Part D sponsors to disclose plan information, including: service area, benefits, access, grievance and appeals procedures, and quality improvement/assurance requirements. MA organizations and sponsors may send the ANOC separately from the EOC, but must send the ANOC for enrollee receipt by September 30. The required due date for the EOC is 15 days prior to the start of the AEP. CMS requires MA organization and Part D sponsors to submit marketing materials to CMS for review prior to the MA organization or sponsor distributing those materials to the public. In section 1851(h), paragraphs (1), (2), and (3) establish this requirement for MA organizations. Section 1860D– 1(b)(1)(B)(vi) directs Part D sponsors to VerDate Sep<11>2014 18:05 Oct 04, 2022 Jkt 259001 follow the same requirements in section 1851(h) that MA organizations must follow for this purpose. Form number: CMS–10260 (OMB control number: 0938–1051); Frequency: Annually; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 800; Number of Responses: 48,439; Total Burden Hours: 33,419.50. (For questions regarding this collection contact Elizabeth Jacob at 410–786– 8658). 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP); Use: Medicare Advantage organizations (MAO) and Prescription Drug Plans (PDP) are required to submit an actuarial pricing ‘‘bid’’ for each plan offered to Medicare beneficiaries for approval by CMS. The MAOs and PDPs use the Bid Pricing Tool (BPT) software to develop their actuarial pricing bid. The competitive bidding process defined by the ‘‘The Medicare Prescription Drug, Improvement, and Modernization Act’’ (MMA) applies to both the MA and Part D programs. It is an annual process that encompasses the release of the MA rate book in April, the bid’s that plans submit to CMS in June, and the release of the Part D and RPPO benchmarks, which typically occurs in August. Form number: CMS–10142 (OMB control number: 0938–0944); Frequency: Annually; Affected Public: Private Sector, Business or other forprofits, Not-for-profit institutions; Number of Respondents: 555; Number of Responses: 4,995; Total Burden Hours: 149,850. (For questions regarding this collection contact Rachel Shevland at 410–786–3026). Dated: September 30, 2022. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2022–21657 Filed 10–4–22; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. AGENCY: ACTION: PO 00000 Notice. Frm 00040 Fmt 4703 Sfmt 4703 The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public via webcast. The committee will discuss and vote on a recommendation related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-positive organ transplantation. DATES: The meeting will take place virtually on Thursday, November 17, 2022 from approximately 10 a.m.–3 p.m. eastern time (ET). Meeting times are tentative and subject to change. The confirmed times and agenda items for the meeting will be posted on the ACBTSA web page at https:// www.hhs.gov/oidp/advisory-committee/ blood-tissue-safety-availability/ meetings/2022-11-17/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal Officer for the ACBTSA; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Rockville, MD 20852. Email: ACBTSA@hhs.gov. Phone: 202–795– 7608. SUPPLEMENTARY INFORMATION: On the day of the meeting, please go to https:// www.hhs.gov/live/ to view the meeting. The public will have an opportunity to present their views to the ACBTSA by submitting a written public comment. Comments should be pertinent to the meeting discussion. Persons who wish to provide written public comment should review instructions at https://www.hhs.gov/ oidp/advisory-committee/blood-tissuesafety-availability/meetings/2022-11-17/ index.html and respond by midnight November 9, 2022, ET. Written public comments will be accessible to the public on the ACBTSA web page prior to the meeting. Background and Authority: The ACBTSA is a discretionary Federal advisory committee and is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92– 463, as amended (5 U.S.C. app), which sets forth standards for the formation and use of advisory committees. The ACBTSA functions to provide advice to the Secretary through the Assistant Secretary for Health on a range of policy issues to include: (1) Identification of public health issues through surveillance of blood and tissue safety issues with national survey and data SUMMARY: E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 87, No. 192 / Wednesday, October 5, 2022 / Notices tools; (2) identification of public health issues that affect availability of blood, blood products, and tissues; (3) broad public health, ethical, and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood, blood products, and tissues; (5) risk communications related to blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and tissues. The Committee has met regularly since its establishment in 1997. Dated: September 23, 2022. James J. Berger, Designated Federal Officer, Advisory Committee on Blood and Tissue Safety and Availability, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2022–21620 Filed 10–4–22; 8:45 am] BILLING CODE 4150–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting jspears on DSK121TN23PROD with NOTICES Pursuant to section 10(d) 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 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. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Global Infectious Disease Research Administration Development Award for Low- and Middle-Income Country Institutions (G11 Clinical Trial Not Allowed). Date: October 27, 2022. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G33, Rockville, MD 20892 (Virtual Meeting). Contact Person: Poonam Pegu, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious VerDate Sep<11>2014 18:05 Oct 04, 2022 Jkt 259001 60405 Diseases, National Institutes of Health 5601 Fishers Lane, Room 3G33, Rockville, MD 20852, 240–292–0719, poonam.pegu@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) [FR Doc. 2022–21563 Filed 10–4–22; 8:45 am] Dated: September 29, 2022. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health [FR Doc. 2022–21597 Filed 10–4–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) 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 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. Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Transition to Independence Study Section. Date: November 17–18, 2022. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge I, 6705 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Giuseppe Pintucci, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 205–H, Bethesda, MD 20892, (301) 827–7969, Pintuccig@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Dated: September 29, 2022. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute on Minority Health and Health Disparities; Cancellation of Meeting Notice is hereby given of the cancellation of the National Institute on Minority Health and Health Disparities Special Emphasis Panel, October 20, 2022, 11:00 a.m. to October 20, 2022, 6:00 p.m., National Institutes of Health, Gateway Plaza, 7201 Wisconsin Ave., Bethesda, MD 20817 which was published in the Federal Register on September 14, 2022, FR Doc 2022– 19885, 87 FR 56429. This notice is being amended to announce that the meeting is cancelled and will not be rescheduled. Dated: September 29, 2022. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–21567 Filed 10–4–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 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. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; NINDS Outstanding Investigator Review. Date: November 1–3, 2022. E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 87, Number 192 (Wednesday, October 5, 2022)]
[Notices]
[Pages 60404-60405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Advisory Committee on Blood and Tissue Safety and 
Availability

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: The U.S. Department of Health and Human Services is hereby 
giving notice that the Advisory Committee on Blood and Tissue Safety 
and Availability (ACBTSA) will hold a virtual meeting. The meeting will 
be open to the public via webcast. The committee will discuss and vote 
on a recommendation related to the implementation of the HIV Organ 
Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-
positive organ transplantation.

DATES: The meeting will take place virtually on Thursday, November 17, 
2022 from approximately 10 a.m.-3 p.m. eastern time (ET). Meeting times 
are tentative and subject to change. The confirmed times and agenda 
items for the meeting will be posted on the ACBTSA web page at https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2022-11-17/ when this information becomes available.

FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal 
Officer for the ACBTSA; Office of Infectious Disease and HIV/AIDS 
Policy, Office of the Assistant Secretary for Health, Department of 
Health and Human Services, Tower Building, 1101 Wootton Parkway, 
Rockville, MD 20852. Email: [email protected]. Phone: 202-795-7608.

SUPPLEMENTARY INFORMATION: On the day of the meeting, please go to 
https://www.hhs.gov/live/ to view the meeting. The public 
will have an opportunity to present their views to the ACBTSA by 
submitting a written public comment. Comments should be pertinent to 
the meeting discussion. Persons who wish to provide written public 
comment should review instructions at https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2022-11-17/ and respond by midnight November 9, 2022, ET. Written 
public comments will be accessible to the public on the ACBTSA web page 
prior to the meeting.
    Background and Authority: The ACBTSA is a discretionary Federal 
advisory committee and is governed by the provisions of the Federal 
Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. 
app), which sets forth standards for the formation and use of advisory 
committees. The ACBTSA functions to provide advice to the Secretary 
through the Assistant Secretary for Health on a range of policy issues 
to include: (1) Identification of public health issues through 
surveillance of blood and tissue safety issues with national survey and 
data

[[Page 60405]]

tools; (2) identification of public health issues that affect 
availability of blood, blood products, and tissues; (3) broad public 
health, ethical, and legal issues related to the safety of blood, blood 
products, and tissues; (4) the impact of various economic factors 
(e.g., product cost and supply) on safety and availability of blood, 
blood products, and tissues; (5) risk communications related to blood 
transfusion and tissue transplantation; and (6) identification of 
infectious disease transmission issues for blood, organs, blood stem 
cells and tissues. The Committee has met regularly since its 
establishment in 1997.

    Dated: September 23, 2022.
James J. Berger,
Designated Federal Officer, Advisory Committee on Blood and Tissue 
Safety and Availability, Office of Infectious Disease and HIV/AIDS 
Policy.
[FR Doc. 2022-21620 Filed 10-4-22; 8:45 am]
BILLING CODE 4150-41-P
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