Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal, 65916-65917 [2024-18004]
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lotter on DSK11XQN23PROD with NOTICES1
65916
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Notices
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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 Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Prior
Authorization Demonstration for Certain
Ambulatory Surgical Center (ASC)
Services; Use: Section 402(a)(1)(J) of the
Social Security Amendments of 1967
(42 U.S.C. 1395b–1(a)(1)(J)) authorizes
the Secretary to ‘‘develop or
demonstrate improved methods for the
investigation and prosecution of fraud
in the provision of care or services
under the health programs established
by the Social Security Act (the Act).’’
Pursuant to this authority, CMS seeks to
develop and implement a Medicare
demonstration project, which CMS
believes will assist in developing
improved procedures for the
identification, investigation, and
prosecution of Medicare fraud occurring
in ambulatory surgical centers providing
services to Medicare beneficiaries. The
information required for the prior
authorization request includes all
documentation necessary to show that
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the service meets applicable Medicare
coverage, coding, and payment rules.
Prior to rendering the services, ASC
providers should submit this
information to the Medicare
Administrative Contractors (MACs).
Trained clinical reviewers at the MACs
will review the information required for
this collection to determine if the
requested services are medically
necessary and meet Medicare
requirements. If an ASC provider does
not submit a prior authorization request
before rendering the service and
submitting a claim to Medicare for
payment, the MAC will request the
required information from the ASC
provider to determine if the service
meets applicable Medicare coverage,
coding, and payment rules before the
claim is paid. Form Number: CMS–
10884 (OMB Control Number: 0938–
NEW); Frequency: Occasionally;
Affected Public: Business or other forprofits; Number of Respondents: 4,038;
Number of Responses: 95,579; Total
Annual Hours: 59,904. (For policy
questions regarding this collection
contact Kelly Wojciechowski at
kelly.wojciechowski@cms.hhs.gov or
Justin Carlisle at Justin.Carlisle@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–17969 Filed 8–12–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0691]
Advisory Committee; Peripheral and
Central Nervous System Drugs
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Peripheral and Central Nervous System
Drugs Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Peripheral and
Central Nervous System Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
June 4, 2026, expiration date.
SUMMARY:
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Frm 00081
Fmt 4703
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Authority for the Peripheral and
Central Nervous System Drugs Advisory
Committee will expire on June 4, 2026,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Jessica Seo, Center for Drug Evaluation
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001,
PCNS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Peripheral and Central
Nervous System Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of neurologic
diseases, and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
Pursuant to its Charter, the Committee
shall consist of a core of 12 voting
members including two Chairpersons.
Members and the Chairpersons are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
neurology, pediatric neurology,
epidemiology, statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Non-Federal members of this
committee will serve as Special
Government Employees or
representatives. Federal members will
serve as Regular Government Employees
or Ex-Officios. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, who is
identified with consumer interests and
is recommended by either a consortium
of consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
DATES:
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13AUN1
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Notices
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
Peripheral-and-Central-NervousSystem-Drugs-advisory-committee or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees. For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
lotter on DSK11XQN23PROD with NOTICES1
Dated: August 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18004 Filed 8–12–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0955–0019]
Agency Information Collection
Request; 30-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
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 September 12,
2024.
SUMMARY:
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: New.
OMB No. 0955–0019.
Abstract: The Department of Health
and Human Services, The Office of the
Assistant Secretary for Technology
Policy and Office of the National
Coordinator for Health Information
Technology, Electronic health
information exchange (HIE) was one of
three goals specified by Congress in the
2009 Health Information Technology for
ADDRESSES:
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65917
Economic and Clinical Health (HITECH)
Act to ensure that the $30 billion federal
investment in certified electronic health
records (EHRs) resulted in higherquality, 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. health care 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.
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]]>Agencies
[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65916-65917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18004]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0691]
Advisory Committee; Peripheral and Central Nervous System Drugs
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Peripheral and Central Nervous System
Drugs Advisory Committee by the Commissioner of Food and Drugs (the
Commissioner). The Commissioner has determined that it is in the public
interest to renew the Peripheral and Central Nervous System Drugs
Advisory Committee for an additional 2 years beyond the charter
expiration date. The new charter will be in effect until the June 4,
2026, expiration date.
DATES: Authority for the Peripheral and Central Nervous System Drugs
Advisory Committee will expire on June 4, 2026, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Jessica Seo, Center for Drug
Evaluation Research, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Peripheral and
Central Nervous System Drugs Advisory Committee (the Committee). The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases, and makes appropriate
recommendations to the Commissioner of Food and Drugs.
Pursuant to its Charter, the Committee shall consist of a core of
12 voting members including two Chairpersons. Members and the
Chairpersons are selected by the Commissioner or designee from among
authorities knowledgeable in the fields of neurology, pediatric
neurology, epidemiology, statistics, and related specialties. Members
will be invited to serve for overlapping terms of up to 4 years. Non-
Federal members of this committee will serve as Special Government
Employees or representatives. Federal members will serve as Regular
Government Employees or Ex-Officios. The core of voting members may
include one technically qualified member, selected by the Commissioner
or designee, who is identified with consumer interests and is
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one non-voting representative member who is
identified with industry interests. There may also be an alternate
industry representative.
[[Page 65917]]
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members) or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/Peripheral-and-Central-Nervous-System-Drugs-advisory-committee or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact
that no change has been made to the committee name or description of
duties, no amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees. For general information related to FDA advisory committees,
please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: August 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18004 Filed 8-12-24; 8:45 am]
BILLING CODE 4164-01-P
