Agency Information Collection Activities: Proposed Collection; Comment Request, 12193-12194 [2021-04296]
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Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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: Extension of a currently
approved collection; Title of
Information Collection: New
Technology Services for Ambulatory
Payment Classifications under the
Outpatient Prospective Payment
System; Use: Section 1833(t)(6) of the
Social Security Act (the Act) states,
‘‘The Secretary shall provide for an
additional payment under this
paragraph for any of the following that
are provided as part of a covered OPD
service (or group of services).’’ In
accordance with the Act, CMS needs to
keep pace with emerging new
technologies and make them accessible
to Medicare beneficiaries in a timely
manner. It is necessary that we continue
to collect appropriate information from
interested parties such as hospitals,
medical device manufacturers,
pharmaceutical companies and others
that bring to our attention specific
services that they wish us to evaluate for
New Technology Ambulatory Payment
Classifications (APC) payment.
The information that we seek to
continue to collect is necessary to
determine whether certain new services
are eligible for payment in New
Technology APCs, to determine
appropriate coding and to set an
appropriate payment rate for the new
technology service. The intent of these
provisions is to ensure timely
beneficiary access to new and
appropriate technologies.
Both the New Technology APC
provision and the transitional passthrough provisions provide ways for
ensuring appropriate payment for new
technologies for which the use and costs
are not adequately represented in the
base year claims data on which the
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outpatient PPS is constructed. Although
individual drugs and biologicals and
categories of medical devices will
receive transitional pass-through
payments for 2 to 3 years from the date
payment is initiated for the specific item
or category, the underlying statutory
provision is permanent and provides an
on-going mechanism for reflecting the
introduction of new items into the
payment structure in a timely manner.
New Technology APCs are designed to
allow appropriate payment for new
technology services that are not covered
by the transitional pass-through
provisions. Form Number: CMS–10054
(OMB control number: 0938–0272);
Frequency: Yearly; Affected Public:
Private Sector, Business or other forprofits; Number of Respondents: 10;
Total Annual Responses: 10; Total
Annual Hours: 160. (For policy
questions regarding this collection
contact Allison Bramlett at 410–786–
6556.)
2. Type of Information Collection
Request: Reinstatement with change;
Title of Information Collection:
Evaluating Coverage to Care in
Communities; Use: The purpose of this
study is to extend our understanding
from RAND Corporation’s prior study of
how C2C materials are used. This will
be accomplished by assessing what
materials best serve partners in their
efforts to activate, engage, and empower
consumers and how consumers engage
with or respond to C2C materials. These
data collection efforts will also serve the
goals of informing future consumer
messaging and creating a long-term
feedback loop for maintaining a
relevant, successful, and engaging C2C
initiative. Initial survey results will be
available in early 2022, which may help
to fine-tune the strategy for the 2022
relaunch of C2C and will influence
strategies and techniques going forward.
Further, this study opens the door for a
feedback loop that may include future
consumer testing to adjust and improve
C2C outreach strategies to meet the
changing needs of various targeted
populations.
The C2C Logic Model serves as the
basis of this package. The goal of C2C
is to improve the health of all
populations, especially vulnerable and
newly insured populations, by helping
consumers understand their health
insurance coverage and connecting
individuals to primary care and
preventive services. The urgency of
achieving this goal is underscored by
the COVID–19 pandemic, which has
discouraged patients from seeking
preventive care and hampered patients
from properly managing chronic
conditions at a time when preserving
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12193
emergency room and hospital bed
capacity is paramount.
There are three main paths of
information dissemination covered by
the C2C Logic Model (see Exhibit 1): (a)
A direct path to the consumer, (b) a path
to the consumer through a partner, and
(c) a role for performance measurement
in improving performance (i.e., desired
effect and how C2C can improve). The
partner and consumer surveys in the
present evaluation build upon RAND’s
earlier study by adapting their questions
to the C2C Logic Model and using
similar survey methodologies in three to
four targeted geographic areas known to
have received a high volume of C2C
materials and messages. These research
questions and sub-questions correspond
to the short-term and intermediate-term
outcomes on the C2C Logic Model.
Thus, the foregoing is a reformulation of
questions answered by RAND and a
consideration of additional questions.
Form Number: CMS–10632 (OMB
control number: 0938–1342); Frequency:
Yearly; Affected Public: Individuals and
Households, Business or other forprofits, Not-for-profits institutions;
Number of Respondents: 460; Total
Annual Responses: 460; Total Annual
Hours: 152. (For policy questions
regarding this collection contact Ashley
Peddicord-Auston at 410–786–0757.)
Dated: February 25, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–04303 Filed 3–1–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–372(S)]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice; withdrawal.
AGENCY:
On Thursday, February 25, 2021, the
Centers for Medicare & Medicaid
Services (CMS) published a 60-day
notice entitled, ‘‘Agency Information
Collection Activities: Proposed
Collection; Comment Request.’’ That
notice invited public comments on the
following information collection
request: Title: Annual Report on Home
and Community Based Services Waivers
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12194
Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices
and Supporting Regulations; Form
Number: CMS–372(S); and OMB Control
Number: 0938–0272. Through the
publication of this document we are
withdrawing that notice (FR document:
2021–03916) in its entirety. While the
notice published in error, it will be
resubmitted for publication and public
comment when ready.
Dated: February 25, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–04296 Filed 3–1–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP, the full
meeting agenda, and instructions for
linking to public access will be posted
on the SACHRP website at https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Tuesday, March 23rd, 2021, from 11:00
a.m. until 4:30 p.m., and Wednesday,
March 24, 2021, from 11:00 a.m. until
4:30 p.m. (times are tentative and
subject to change). The confirmed times
and agenda will be posted on the
SACHRP website when this information
becomes available.
ADDRESSES: This meeting will be held
via webcast. Members of the public may
also attend the meeting via webcast.
Instructions for attending via webcast
will be posted one week prior to the
meeting at https://www.hhs.gov/ohrp/
sachrp-committee/meetings/.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
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SUMMARY:
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Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification or
coordination.
The SACHRP meeting will open to the
public at 11:00 a.m., on Tuesday, March
23, 2021, followed by opening remarks
from Dr. Jerry Menikoff, Director of
OHRP and Dr. Douglas Diekema,
SACHRP Chair. The meeting will begin
with presentation of recommendations
on Justice as an Ethical Concept in 45
CFR 46, followed by an expert panel
discussion of draft recommendations on
Mandatory Exploratory Biopsies in
Research. The day will conclude with
discussion of a new SACHRP topic, IRB
Authority to Restrict Use of Data in
Research. March 24th will include
presentation of Interactions between
Sponsors, Clinical Trial Sites, and
Research Subjects, and lastly,
Consideration of Risks to Bystanders in
Research. Other topics may be added;
for the full and updated meeting agenda,
see https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/.
The public will have an opportunity
to send comments to SACHRP during
the meeting’s public comment session
or to submit written public comments in
advance. Persons who wish to provide
public comments should review
instructions at https://www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html and respond by midnight
Wednesday, March 18th, 2021, ET.
Individuals submitting written
statements as public comment should
submit their comments to SACHRP at
SACHRP@hhs.gov. Comments are
limited to three minutes each.
Time will be allotted for public
comment on both days. Note that public
SUPPLEMENTARY INFORMATION:
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comment must be relevant to topics
currently being addressed by SACHRP.
Dated: February 22, 2021.
Julia G. Gorey,
Executive Director, SACHRP, Office for
Human Research Protections.
[FR Doc. 2021–04244 Filed 3–1–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 on
Drug Abuse Special Emphasis Panel; NIDA–
L Conflict SEP.
Date: March 25, 2021
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Preethy Nayar, Ph.D.
Scientific Review Officer Scientific Review
Branch National Institute on Drug Abuse,
NIH 301 North Stonestreet Avenue Bethesda,
MD 20892, 301–443–4577, nayarp2@
csr.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Implementing the HIV Service Cascade for
Justice-Involved Populations (U01—Clinical
Trial Optional).
Date: March 30, 2021.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Sheila Pirooznia, Ph.D.;
Scientific Review Officer, Division of
Extramural Review, Scientific Review
Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue Bethesda,
MD 20892, (301) 496–9350 sheila.pirooznia@
nih.gov.
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Agencies
[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12193-12194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04296]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-372(S)]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
On Thursday, February 25, 2021, the Centers for Medicare & Medicaid
Services (CMS) published a 60-day notice entitled, ``Agency Information
Collection Activities: Proposed Collection; Comment Request.'' That
notice invited public comments on the following information collection
request: Title: Annual Report on Home and Community Based Services
Waivers
[[Page 12194]]
and Supporting Regulations; Form Number: CMS-372(S); and OMB Control
Number: 0938-0272. Through the publication of this document we are
withdrawing that notice (FR document: 2021-03916) in its entirety.
While the notice published in error, it will be resubmitted for
publication and public comment when ready.
Dated: February 25, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-04296 Filed 3-1-21; 8:45 am]
BILLING CODE 4120-01-P