Agency Information Collection Activities: Submission for OMB Review; Comment Request, 56023-56024 [2023-17731]
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Federal Register / Vol. 88, No. 158 / Thursday, August 17, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PaperworkReductionActof1995/PRAListing.
Centers for Medicare & Medicaid
Services
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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: Revision of the currently
approved collection; Title of
Information Collection: Standards
Related to Reinsurance, Risk Corridors,
and Risk Adjustment; Use: The data
collection and reporting requirements
will be used by HHS to run the
permanent risk adjustment program,
including validation of data submitted
by issuers, on behalf of States that
requested HHS to run it for them. Risk
adjustment is one of three market
stability programs established by the
Patient Protection and Affordable Care
Act and is intended to mitigate the
impact of adverse selection in the
individual and small group health
insurance markets inside and outside of
the Health Insurance Exchanges. HHS
will also use this data to adjust the
payment transfer formula for risk
associated with high-cost enrollees.
Issuers and providers can use the
alternative reporting requirements for
mental and behavioral health records
described herein to comply with State
privacy laws. Form Number: CMS–
10401 (OMB control number: 0938–
1155); Frequency: Annually; Affected
Public: State, local, or Tribal
governments; Number of Respondents:
650; Total Annual Responses: 3,250;
Total Annual Hours: 4,154,150. (For
policy questions regarding this
collection contact Jacqueline Wilson at
(301–492–4400.)
SUPPLEMENTARY INFORMATION:
[Document Identifier: CMS–10401 and CMS–
10853]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by September 18,
2023.
DATES:
Written 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.
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/
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56023
2. 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.
HHS will request information from
uninsured (or self-pay) individuals in
order to initiate patient-provider dispute
resolution process. This information
will be used to help determine
eligibility for the patient-provider
dispute resolution process and is
necessary for determining which
provider or facility should be contacted
for dispute resolution. Providers and
facilities are required to submit
information to SDR entities to inform
the SDR entity’s payment
determinations. Form Number: CMS–
10853 (OMB control number: 0938–
NEW); Frequency: Occasionally;
Affected Public: Individuals and
Households, Private Sector, Business or
other for-profits; Number of
Respondents: 26,659; Total Annual
Responses: 26,659; Total Annual Hours:
322,189. (For policy questions regarding
E:\FR\FM\17AUN1.SGM
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56024
Federal Register / Vol. 88, No. 158 / Thursday, August 17, 2023 / Notices
this collection contact Daniel Kidane at
(301–786–0000.)
Dated: August 14, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–17731 Filed 8–16–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3104]
Optimizing the Use of Postapproval
Pregnancy Safety Studies; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Optimizing
the Use of Postapproval Pregnancy
Safety Studies’’ convened by the DukeMargolis Center for Health Policy and
supported by a cooperative agreement
between FDA and Duke-Margolis. This
workshop will include discussions of
designs of postapproval pregnancy
safety studies for drug and biological
products regulated by the Center for
Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation
and Research (CBER) and experiences
with implementing these studies. The
workshop also will include discussion
of considerations for further
development of a framework that
describes how data from different types
of postapproval pregnancy safety
studies might optimally be used when it
has been determined that this data
should be collected.
DATES: The public workshop will be
held in person and virtually on
September 18, 2023, from 10 a.m. to 4
p.m., Eastern Daylight Time, and on
September 19, 2023, from 10 a.m. to
2:30 p.m. Either electronic or written
comments on this public workshop
must be submitted by November 30,
2023. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held in person at the National Press
Club, 529 14th St. NW, Washington, DC
20045 and virtually using the Zoom
Platform. The link for the public
workshop will be sent to registrants
upon registration for virtual attendance.
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SUMMARY:
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You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered
for the subsequent workshop report
describing the proposed framework,
which will be published by October 2,
2024. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
on November 30, 2023. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are received
on or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–3104 for ‘‘Optimizing the Use
of Postapproval Pregnancy Safety
Studies.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
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and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions: To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments. You
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Commander Vicky Chan, Food and Drug
Administration, CDER, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3404,
Silver Spring, MD 20993, 301–796–
1639, Vicky.Chan@fda.hhs.gov or Anne
Taylor, CBER, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993, 240–402–7911,
Anne.Taylor@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Pages 56023-56024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17731]
[[Page 56023]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10401 and CMS-10853]
Agency Information Collection Activities: Submission for OMB
Review; 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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by September 18, 2023.
ADDRESSES: Written 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.
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 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: Revision of the
currently approved collection; Title of Information Collection:
Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment;
Use: The data collection and reporting requirements will be used by HHS
to run the permanent risk adjustment program, including validation of
data submitted by issuers, on behalf of States that requested HHS to
run it for them. Risk adjustment is one of three market stability
programs established by the Patient Protection and Affordable Care Act
and is intended to mitigate the impact of adverse selection in the
individual and small group health insurance markets inside and outside
of the Health Insurance Exchanges. HHS will also use this data to
adjust the payment transfer formula for risk associated with high-cost
enrollees. Issuers and providers can use the alternative reporting
requirements for mental and behavioral health records described herein
to comply with State privacy laws. Form Number: CMS-10401 (OMB control
number: 0938-1155); Frequency: Annually; Affected Public: State, local,
or Tribal governments; Number of Respondents: 650; Total Annual
Responses: 3,250; Total Annual Hours: 4,154,150. (For policy questions
regarding this collection contact Jacqueline Wilson at (301-492-4400.)
2. 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.
HHS will request information from uninsured (or self-pay)
individuals in order to initiate patient-provider dispute resolution
process. This information will be used to help determine eligibility
for the patient-provider dispute resolution process and is necessary
for determining which provider or facility should be contacted for
dispute resolution. Providers and facilities are required to submit
information to SDR entities to inform the SDR entity's payment
determinations. Form Number: CMS-10853 (OMB control number: 0938-NEW);
Frequency: Occasionally; Affected Public: Individuals and Households,
Private Sector, Business or other for-profits; Number of Respondents:
26,659; Total Annual Responses: 26,659; Total Annual Hours: 322,189.
(For policy questions regarding
[[Page 56024]]
this collection contact Daniel Kidane at (301-786-0000.)
Dated: August 14, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-17731 Filed 8-16-23; 8:45 am]
BILLING CODE 4120-01-P
