Agency Forms Undergoing Paperwork Reduction Act Review, 12362-12363 [2023-03961]

Download as PDF 12362 Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices including two deaths, have been reported among AS fabrication workers in the United States. The anticipated impacts of this project are increased understanding of industry scale, practices, and medical monitoring, and increased collaboration and communication to inform the AS Countertop industry of industry hazards, methods to mitigate exposure, and improve medical surveillance. Understanding how or if current RCS recommendations and regulations are used by various AS Countertop fabrication facilities will identify approaches for improved intervention. The purpose of the proposed collection is to conduct a survey with AS Countertop fabrication facilities to better understand: (1) work practices and controls related to respirable crystalline silica; (2) barriers or facilitators to implementation of medical and exposure monitoring requirements; (3) identify areas for potential intervention; and (4) identify countertop fabrication facilities willing to participate in future NIOSH exposure and health research. The estimate of burden hours is based on an internal pilot test of the survey instrument. The average time for reviewing instructions, gathering mock information, and completing the survey was between 10–30 minutes. For the purposes of estimating burden hours, the median time to complete the survey is used. An estimated 8,600 respondents are anticipated to participate in the survey. for 2,150 annual burden hours. There are no costs to respondents other than their time to participate. ESTIMATED ANNUALIZED BURDEN HOURS Form name Facility Managers/Owners .............................. Workplace Survey .......................................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2023–03959 Filed 2–24–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–23–22HY] Agency Forms Undergoing Paperwork Reduction Act Review ddrumheller on DSK120RN23PROD with NOTICES Number of respondents Type of respondents In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled, ‘‘Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA–IND) for Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children (IND 116039/CDC #6402),’’ to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on August 22, 2022, to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget VerDate Sep<11>2014 20:06 Feb 24, 2023 Jkt 259001 is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. 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. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 8,600 Number of responses per respondent 1 Average burden per response (in hours) 15/60 Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA–IND) for ‘‘Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children’’ (IND 116039/CDC #6402)— New—Office of Science (OS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Monkeypox is a zoonosis, caused by the Orthopoxvirus (OPXV) Monkeypox virus (MPXV), and is endemic to forested areas of West and Central Africa. In humans, infection with MPXV can lead to a smallpox-like illness with fatal outcomes in up to 11% of patients without prior smallpox vaccination. Since May 2022, clusters of monkeypox cases, have been reported in 19 countries that do not normally have monkeypox, and the number of confirmed cases in the U.S. is rapidly increasing. Tecovirimat (TPOXX) is FDAapproved for the treatment of human smallpox disease caused by Variola virus in adults and children. However, its use for other orthopoxvirus infections, including monkeypox, is not approved by the FDA. CDC currently holds a non-research expanded access Investigational New Drug (EA–IND) protocol that allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus E:\FR\FM\27FEN1.SGM 27FEN1 12363 Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices infections, including monkeypox, in adults and children of all ages. FDA regulations require that an Institutional Review Board (IRB) review, approve and maintain oversight of the activities under the EA–IND as set forth in 21 CFR parts 50, 56, and 312. The CDC IRB is positioned to serve as the central IRB for review and approval of the EA–IND consistent 21 CFR 56.114. This arrangement allows facilities to use or rely on the CDC IRB for centralized review and approval for this protocol in place of review by the site-specific IRB to help reduce duplication of effort, delays, and increased expenses. Any facility that receives tecovirimat for treatment of orthopoxvirus infection under the EA–IND may elect to rely on the CDC IRB to meet FDA’s regulatory requirements. The IRB review is required by FDA under the CDC’s approved EA–IND. Therefore, CDC must maintain records of which facilities have elected to rely on the CDC IRB for centralized review and which facilities elect to obtain IRB review on their own. CDC will use collected data to track and document the institutions relying on the CDC IRB so they can provide TPOXX treatment to their patients with monkeypox under the EA–IND. This collection was initially approved as an Emergency ICR in August 2022 (OMB Control No. 0920–1366), and is being submitted here to create a standard version of the collection. CDC requests OMB approval for an estimated 1,333 annual burden hours. There is no cost to respondents other than their time to participate. ESTIMATED ANNUALIZED BURDEN HOURS Form name Hospital/IRB Administrators ............................ CDC IRB Authorization Agreement (for review). CDC IRB Authorization Agreement (for completion and submission to CDC). Hospital/IRB Administrators ............................ Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2023–03961 Filed 2–24–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3430–FN] Application From the Joint Commission (TJC) for Continued Approval of its Psychiatric Hospital Accreditation Program Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces our decision to approve the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs. DATES: This notice is effective February 25, 2023 through February 25, 2029. FOR FURTHER INFORMATION CONTACT: Danielle Adams (410) 786–8818, Donald Howard (410) 786–6764 or Lillian Williams (410) 786–8636. SUPPLEMENTARY INFORMATION: SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES Number of respondents Type of respondent I. Background Under the Medicare program, eligible beneficiaries may receive covered services from a psychiatric hospital VerDate Sep<11>2014 20:06 Feb 24, 2023 Jkt 259001 provided certain requirements are met. Section 1861(f) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a psychiatric hospital. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 482, subpart E, specify the minimum conditions that a psychiatric hospital must meet to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for psychiatric hospitals. Generally, to enter into a provider agreement, a psychiatric hospital must first be certified by a State Survey Agency as complying with the conditions or requirements set forth in part 482 subpart E of our regulations. Thereafter, the psychiatric hospital is subject to regular surveys by a State Survey Agency to determine whether it continues to meet these requirements. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may treat the provider entity as having met those conditions; that is, we may ‘‘deem’’ the provider entity as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation. If an AO is recognized by the Secretary of the Department of Health and Human Services (the Secretary) as having standards for accreditation that PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Number responses per respondent Avg. burden per response (in hours) 500 1 1 500 10 10/60 meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body’s approved program may be deemed to meet the Medicare conditions. A national AO applying for approval of its accreditation program under part 488, subpart A, must provide Centers for Medicare & Medicaid Services (CMS) with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AO are set forth at § 488.5. The regulations at § 488.5(e)(2)(i) require AO to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS. The Joint Commission’s current term of approval for their psychiatric hospital accreditation program expires February 25, 2023. II. Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS approval of an accreditation program is conducted in a timely manner. The Act provides no more than 210 days after the date of receipt of a complete application, including any documentation necessary to make the determination, for CMS to complete its application review process. Within 60 days after receiving a complete application, we must publish a notice in the Federal Register that identifies the national accrediting body making the request, describes the request, and provides no less than a 30-day public E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12362-12363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03961]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-22HY]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled, ``Centralized Institutional Review for the 
CDC Expanded Access Investigational New Device (EA-IND) for Use of 
Tecovirimat (TPOXX[supreg]) for Treatment of Human Non-Variola 
Orthopoxvirus Infections in Adults and Children (IND 116039/CDC 
#6402),'' to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on August 22, 
2022, to obtain comments from the public and affected agencies. CDC 
received two comments related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. 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. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Centralized Institutional Review for the CDC Expanded Access 
Investigational New Device (EA-IND) for ``Use of Tecovirimat 
(TPOXX[supreg]) for Treatment of Human Non-Variola Orthopoxvirus 
Infections in Adults and Children'' (IND 116039/CDC #6402)--New--Office 
of Science (OS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Monkeypox is a zoonosis, caused by the Orthopoxvirus (OPXV) 
Monkeypox virus (MPXV), and is endemic to forested areas of West and 
Central Africa. In humans, infection with MPXV can lead to a smallpox-
like illness with fatal outcomes in up to 11% of patients without prior 
smallpox vaccination.
    Since May 2022, clusters of monkeypox cases, have been reported in 
19 countries that do not normally have monkeypox, and the number of 
confirmed cases in the U.S. is rapidly increasing.
    Tecovirimat (TPOXX) is FDA-approved for the treatment of human 
smallpox disease caused by Variola virus in adults and children. 
However, its use for other orthopoxvirus infections, including 
monkeypox, is not approved by the FDA. CDC currently holds a non-
research expanded access Investigational New Drug (EA-IND) protocol 
that allows for the use of tecovirimat for primary or early empiric 
treatment of non-variola orthopoxvirus

[[Page 12363]]

infections, including monkeypox, in adults and children of all ages.
    FDA regulations require that an Institutional Review Board (IRB) 
review, approve and maintain oversight of the activities under the EA-
IND as set forth in 21 CFR parts 50, 56, and 312. The CDC IRB is 
positioned to serve as the central IRB for review and approval of the 
EA-IND consistent 21 CFR 56.114. This arrangement allows facilities to 
use or rely on the CDC IRB for centralized review and approval for this 
protocol in place of review by the site-specific IRB to help reduce 
duplication of effort, delays, and increased expenses. Any facility 
that receives tecovirimat for treatment of orthopoxvirus infection 
under the EA-IND may elect to rely on the CDC IRB to meet FDA's 
regulatory requirements.
    The IRB review is required by FDA under the CDC's approved EA-IND. 
Therefore, CDC must maintain records of which facilities have elected 
to rely on the CDC IRB for centralized review and which facilities 
elect to obtain IRB review on their own. CDC will use collected data to 
track and document the institutions relying on the CDC IRB so they can 
provide TPOXX treatment to their patients with monkeypox under the EA-
IND.
    This collection was initially approved as an Emergency ICR in 
August 2022 (OMB Control No. 0920-1366), and is being submitted here to 
create a standard version of the collection. CDC requests OMB approval 
for an estimated 1,333 annual burden hours. There is no cost to 
respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Number        Avg. burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Hospital/IRB Administrators...........  CDC IRB Authorization                500               1               1
                                         Agreement (for review).
Hospital/IRB Administrators...........  CDC IRB Authorization                500              10           10/60
                                         Agreement (for
                                         completion and
                                         submission to CDC).
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2023-03961 Filed 2-24-23; 8:45 am]
BILLING CODE 4163-18-P
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