Agency Information Collection Activities: Proposed Collection; Comment Request, 27517-27518 [2023-09198]
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Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
seeking OMB approval to renew the preexisting clearance for the Rule. For more
details about the Rule requirements and
the basis for the calculations
summarized below, see 88 FR 11,917.
Your comment—including your name
and your state—will be placed on the
public record of this proceeding.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, such as anyone’s Social
Security number; date of birth; driver’s
license number or other state
identification number or foreign country
equivalent; passport number; financial
account number; or credit or debit card
number. You are also solely responsible
for ensuring that your comment does
not include any sensitive health
information, such as medical records or
other individually identifiable health
information. In addition, your comment
should not include any ‘‘[t]rade secret or
any commercial or financial information
which is . . . privileged or
confidential’’—as provided in Section
6(f) of the FTC Act 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16CFR 4.10(a)(2)—
including, in particular, competitively
sensitive information, such as costs,
sales statistics, inventories, formulas,
patterns devices, manufacturing
processes, or customer names.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023–09279 Filed 5–1–23; 8:45 am]
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Officer, Office of Extramural Research,
Education and Priority Populations,
Agency for Healthcare Research and
Quality, (AHRQ), 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone:
(301) 427–1557.
SUPPLEMENTARY INFORMATION: A Special
Emphasis Panel is a group of experts in
fields related to health care research
who are invited by AHRQ, and agree to
be available, to conduct on an as needed
basis, scientific reviews of applications
for AHRQ support. Individual members
of the Panel do not attend regularly
scheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
The SEP meeting referenced above
will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. App. 2, section 10(d), 5
U.S.C. 552b(c)(4), and 5 U.S.C.
552b(c)(6). Grant applications for
‘‘AHRQ and PCORI Learning Health
System Embedded Scientist Training
and Research Centers (P30)’’ are to be
reviewed and discussed at this meeting.
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.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: April 26, 2023.
Marquita Cullom,
Associate Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–09191 Filed 5–1–23; 8:45 am]
Agency for Healthcare Research and
Quality
BILLING CODE 4160–90–P
Notice of Meeting
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ)
announces a Special Emphasis Panel
(SEP) meeting on ‘‘AHRQ and PCORI
Learning Health System Embedded
Scientist Training and Research Centers
(P30)’’. This SEP meeting will be closed
to the public.
DATES: June 6–7, 2023.
ADDRESSES: Agency for Healthcare
Research and Quality, (Video Assisted
Review), 5600 Fishers Lane, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT:
Jenny Griffith, Committee Management
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SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10853]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
27517
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
July 3, 2023.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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:
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
Contents
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
AGENCY:
SUMMARY:
PO 00000
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William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02MYN1.SGM
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27518
Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
and associated materials (see
ADDRESSES).
CMS 10853 Patient Provider Dispute
Resolution Requirements Related to
Surprise Billing: Part II
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.
ddrumheller on DSK120RN23PROD with NOTICES1
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Patient Provider
Dispute Resolution Requirements
Related to Surprise Billing: Part II; Use:
The Consolidated Appropriations Act,
2021 (CAA), which includes the No
Surprises Act provides Federal
protections against surprise billing and
limits out-of-network cost sharing under
many of the circumstances in which
surprise bills arise most frequently.
The Act adds a new Part E of title
XXVII of the Public Health Service Act
establishing requirements applicable to
providers, and facilities. These include
provisions at new PHS Act sections
2799B–6 which requires providers and
facilities to furnish a good faith estimate
of expected charges upon request or
upon scheduling an item or service for
an individual. Providers and facilities
are required to inquire if an individual
is enrolled in a group health plan, group
or individual health insurance coverage,
a Federal Employees Health Benefits
(FEHB) plan, or a Federal health care
program and if enrolled in a group
health plan, or group or individual
health insurance coverage, or a health
benefits plan under chapter 89 of title 5,
whether the individual is seeking to
have a claim for such item or service
submitted to such plan or coverage
(hereafter referred to as an ‘‘uninsured
(or self-pay) individual’’). In the case
that an uninsured (or self-pay)
individual requesting a good faith
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18:14 May 01, 2023
Jkt 259001
estimate for an item or service or
schedules an item or service to be
furnished, PHS Act section 2799B–
6(2)(B) and the October 2021 interim
final rules at 45 CFR 149.610 require
providers and facilities to furnish the
good faith estimate to the uninsured (or
self-pay) individual.
No Surprises Act section 112 also
adds PHS Act section 2799B–7 as added
by the interim final rules at 45 CFR
149.620 which directs the Secretary of
HHS to establish a process under which
an uninsured (or self-pay) individual
can avail themselves of a patientprovider dispute resolution (PPDR)
process if their billed charges after
receiving an item or service are
substantially in excess of the expected
charges listed in the good faith estimate
furnished by the provider or facility,
pursuant to PHS Act section 2799B–6.
This information collection request
(ICR) focuses on the patient-provider
dispute resolution process requirements
under the October 2021 interim final
rules (October 7, 2021, 86 FR 55980).
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Perceptions of Prescription Drug
Products with Medication Tracking
Capabilities.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Dated: April 26, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
OMB Control Number 0910–NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDAregulated products in carrying out the
provisions of the FD&C Act.
The mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
to ensure that prescription drug
promotional material is truthful,
balanced, and accurately communicated
so that patients and health care
providers can make informed decisions
about treatment options. OPDP’s
research program provides scientific
evidence to help ensure that our
policies related to prescription drug
promotion will have the greatest benefit
to public health. Toward that end, we
have consistently conducted research to
evaluate the aspects of prescription drug
promotion that are most central to our
mission, focusing in particular on three
main topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and the
characteristics of the disease and
product impact the communication and
understanding of prescription drug risks
and benefits. Focusing on target
populations allows us to evaluate how
[FR Doc. 2023–09198 Filed 5–1–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1874]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Perceptions of
Prescription Drug Products With
Medication Tracking Capabilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 1,
2023.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
ADDRESSES:
PO 00000
Frm 00088
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Sfmt 4703
Perceptions of Prescription Drug
Products With Medication Tracking
Capabilities
E:\FR\FM\02MYN1.SGM
02MYN1
Agencies
[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Pages 27517-27518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09198]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10853]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by July 3, 2023.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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/PRA-Listing.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement
[[Page 27518]]
and associated materials (see ADDRESSES).
CMS 10853 Patient Provider Dispute Resolution Requirements Related to
Surprise Billing: Part II
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: New collection (Request
for a new OMB control number); Title of Information Collection: Patient
Provider Dispute Resolution Requirements Related to Surprise Billing:
Part II; Use: The Consolidated Appropriations Act, 2021 (CAA), which
includes the No Surprises Act provides Federal protections against
surprise billing and limits out-of-network cost sharing under many of
the circumstances in which surprise bills arise most frequently.
The Act adds a new Part E of title XXVII of the Public Health
Service Act establishing requirements applicable to providers, and
facilities. These include provisions at new PHS Act sections 2799B-6
which requires providers and facilities to furnish a good faith
estimate of expected charges upon request or upon scheduling an item or
service for an individual. Providers and facilities are required to
inquire if an individual is enrolled in a group health plan, group or
individual health insurance coverage, a Federal Employees Health
Benefits (FEHB) plan, or a Federal health care program and if enrolled
in a group health plan, or group or individual health insurance
coverage, or a health benefits plan under chapter 89 of title 5,
whether the individual is seeking to have a claim for such item or
service submitted to such plan or coverage (hereafter referred to as an
``uninsured (or self-pay) individual''). In the case that an uninsured
(or self-pay) individual requesting a good faith estimate for an item
or service or schedules an item or service to be furnished, PHS Act
section 2799B-6(2)(B) and the October 2021 interim final rules at 45
CFR 149.610 require providers and facilities to furnish the good faith
estimate to the uninsured (or self-pay) individual.
No Surprises Act section 112 also adds PHS Act section 2799B-7 as
added by the interim final rules at 45 CFR 149.620 which directs the
Secretary of HHS to establish a process under which an uninsured (or
self-pay) individual can avail themselves of a patient-provider dispute
resolution (PPDR) process if their billed charges after receiving an
item or service are substantially in excess of the expected charges
listed in the good faith estimate furnished by the provider or
facility, pursuant to PHS Act section 2799B-6. This information
collection request (ICR) focuses on the patient-provider dispute
resolution process requirements under the October 2021 interim final
rules (October 7, 2021, 86 FR 55980).
Dated: April 26, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-09198 Filed 5-1-23; 8:45 am]
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