Agency Information Collection Activities: Proposed Collection; Comment Request; Correction, 62172-62173 [2021-24418]
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62172
Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
PICOTS elements
Publications ..........................
Inclusion criteria
Exclusion criteria
• Mental health comorbidities.
• Menopausal status.
• Receipt of systemic therapy (i.e., none, endocrine therapy, and/or chemotherapy, both).
• Histologic subtype (e.g., invasive ductal carcinoma, invasive lobular carcinoma, DCIS, other).
• Nodal status (i.e., N0, N1, NX, number of positive nodes).
• Nodal assessment (i.e., sentinel lymph node biopsy, axillary lymph node dissection, none).
• Tumor grade.
• Tumor size (i.e., <1 cm, 1–2 cm, 2–3 cm, >3 cm).
• Focality (unifocal vs multifocal).
• Margin status (i.e., positive, <2 mm, 2–3 mm, >3 mm).
• Extensive intraductal component.
• Ki-67 (<20% vs. >= 20%).
• ASTRO or ESTRO risk category (i.e., suitable, cautionary, unsuitable; low,
intermediate, high).
• Germline genetic mutation (e.g., BRCA1, BRCA2, CHEK2, PALB2, ATM,
etc.).
• Cancer-predisposing syndrome.
• Estrogen receptor status.
• Progesterone receptor status.
• Hormone receptor status.
• Lymphovascular invasion.
• HER2 status.
• Prior chemotherapy.
• Monoelectron therapy.
• Dermatologic Rheumatologic conditions (i.e., lupus, scleroderma, rheumatoid
arthritis).
• Dose-fractionation schemes (i.e., accelerated, nonaccelerated, daily vs every
other day vs twice daily, total dose, EQD2).
• Target volumes (i.e., size of expansion on cavity, diameter of the inflated
balloon, size of the planning target volume).
• Motion management.
• Planning parameters (i.e., the diameter of the inflated balloon, the planning
target volume, and the dose distribution organ-at-risk constraints and dose
received [such as ipsilateral breast V50 and V100], number of beams, PTV
coverage goals and constraints).
• Number of treatment fields.
• Image guidance (i.e., MV imaging, kV imaging, cone beam CT, use of clips
for localization).
• Risk of bias (i.e., low, moderate, high).
• Studies published in English as peer reviewed full text. ..................................
• Published after Year 2000.
• Foreign language studies.
• Conference abstracts.
Abbreviations: ASTRO = American Society for Radiation Oncology; ATM = ataxia telangiectasia mutated; BCTOS = Breast Cancer Treatment
Outcomes Scale; BMI = body mass index; BRCA1 = breast cancer 1; BRCA2 = breast cancer 2; CHEK2 = checkpoint kinase 2; cm = centimeter;
CQ = contextual question; CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; DCIS = ductal carcinoma in
situ; EORTC = European Organisation for Research and Treatment of Cancer; ESTRO = European Society for Radiotherapy and Oncology;
FACT–B = Functional Assessment of Cancer Therapy-Breast; EQD2 = Equivalent Dose in 2 Gy fractions; HER2 = human epidermal growth factor receptor 2; KQ = key question; kV = kilovoltage; LENT–SOMA = Late Effects Normal Tissue Task Force- Subjective, Objective, Management,
Analytic; mm = millimeter; MV = megavoltage; N0 = no involved lymph nodes; N1 = 1–3 involved lymph nodes; NX = lymph nodes not assessed;
PALB2 = partner and localizer Of BRCA2; PBI = partial breast irradiation; PICOTS = populations, interventions, comparators, outcomes, timing,
and settings; PTV = planning target volume; RCT = randomized controlled trial; RTOG = Radiation Therapy Oncology Group; SF–36 = Short
Form (36) Health Survey; V50 = volume (%) receiving >= 50% of the prescription dose; V100 = volume (%) receiving >= 100% of the prescription dose; WBI = whole breast irradiation.
Dated: November 2, 2021.
Marquita Cullom,
Associate Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2021–24403 Filed 11–8–21; 8:45 am]
Centers for Medicare & Medicaid
Services
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[Document Identifier: CMS–10790]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction of notice.
AGENCY:
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This document corrects the
information provided for [Document
Identifier: CMS–10790] titled
‘‘Medicare-Funded GME Residency
Positions in accordance with Section
126 of the Consolidated Appropriations
Act, 2020.’’
FOR FURTHER INFORMATION CONTACT:
William N. Parham, III, (410) 786–4669.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In the October 22, 2021, issue of the
Federal Register (86 FR 58664), we
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
published a Paperwork Reduction Act
notice requesting a 60-day public
comment period for the information
collection request identified under
CMS–10790, OMB control number
0938-New, and titled ‘‘Medicare-Funded
GME Residency Positions in accordance
with Section 126 of the Consolidated
Appropriations Act, 2020 (Pub. L. 116–
93).’’
II. Explanation of Error
In the October 22, 2021, notice, the
information provided in the middle of
the middle column on page 58665, was
published with incorrect information in
the ‘‘Use’’ section. This notice corrects
the language found in the ‘‘Use’’ section
in the middle of the middle column on
page 58665. All of the other information
contained in the October 22, 2021,
notice is correct. The related public
comment period remains in effect and
ends December 21, 2021.
III. Correction of Error
In FR Doc. 2021–23107 of October 22,
2021, (86 FR 58664), page 58665, the
language in the middle of the middle
column that begins with ‘‘Use:’’ and
ends with ‘‘in early January 2022’’ is
corrected to read as follows:
Use: The requirements in this rule were
announced in CMS– 1752–P (FY22 IPPS);
however, the PRA package has been under
development until now. The plan, approved
by OMB and CM, is to have the 60-day
Federal Register notice publish and then
have CMS–1752–F3 serve as the required 30day Federal Register notice, with the goal of
approval in early January 2022. If this is not
possible, CMS will publish a standalone 30day Federal Register notice prior to
submitting the information collection request
(CMS–10790) to OMB.
Dated: November 3, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–24418 Filed 11–8–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
jspears on DSK121TN23PROD with NOTICES1
[Document Identifiers: CMS–10792, CMS–
10793, and CMS–367a–e]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
AGENCY:
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ACTION:
Notice.
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
January 10, 2022.
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: lll , 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, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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62173
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
and associated materials (see
ADDRESSES).
CMS–10792 Patient-Reported
Indicator Survey (PaRIS)
CMS–10793 Medicare Advantage and
Prescription Drug Plan Consumer
Assessment of Healthcare Providers
and Systems (CAHPS) Survey Field
Test
CMS–367a–e Medicaid Drug Rebate
Program Labeler Reporting Format
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: PatientReported Indicator Survey (PaRIS); Use:
The Centers for Medicare and Medicaid
Services (CMS) invites comments on a
proposed new Information Collection
Request (ICR) to conduct the
International Survey of People Living
with Chronic Conditions (hereafter
referred to as the PaRIS Survey). This
survey has been developed by a
collaborative workgroup under the
auspices of the Organization for
Economic Cooperation and
Development (OECD), an international
organization that works with
governments, policy makers, and
citizens to shape policies that foster
prosperity, equality, opportunity, and
well-being for all.
The OECD launched the PaRIS
initiative in 2017 to address gaps in
health outcomes measures, particularly
regarding user experiences with health
care services. OECD member countries,
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Agencies
[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62172-62173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24418]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10790]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Correction of notice.
-----------------------------------------------------------------------
SUMMARY: This document corrects the information provided for [Document
Identifier: CMS-10790] titled ``Medicare-Funded GME Residency Positions
in accordance with Section 126 of the Consolidated Appropriations Act,
2020.''
FOR FURTHER INFORMATION CONTACT: William N. Parham, III, (410) 786-
4669.
SUPPLEMENTARY INFORMATION:
I. Background
In the October 22, 2021, issue of the Federal Register (86 FR
58664), we
[[Page 62173]]
published a Paperwork Reduction Act notice requesting a 60-day public
comment period for the information collection request identified under
CMS-10790, OMB control number 0938-New, and titled ``Medicare-Funded
GME Residency Positions in accordance with Section 126 of the
Consolidated Appropriations Act, 2020 (Pub. L. 116-93).''
II. Explanation of Error
In the October 22, 2021, notice, the information provided in the
middle of the middle column on page 58665, was published with incorrect
information in the ``Use'' section. This notice corrects the language
found in the ``Use'' section in the middle of the middle column on page
58665. All of the other information contained in the October 22, 2021,
notice is correct. The related public comment period remains in effect
and ends December 21, 2021.
III. Correction of Error
In FR Doc. 2021-23107 of October 22, 2021, (86 FR 58664), page
58665, the language in the middle of the middle column that begins with
``Use:'' and ends with ``in early January 2022'' is corrected to read
as follows:
Use: The requirements in this rule were announced in CMS- 1752-P
(FY22 IPPS); however, the PRA package has been under development
until now. The plan, approved by OMB and CM, is to have the 60-day
Federal Register notice publish and then have CMS-1752-F3 serve as
the required 30-day Federal Register notice, with the goal of
approval in early January 2022. If this is not possible, CMS will
publish a standalone 30-day Federal Register notice prior to
submitting the information collection request (CMS-10790) to OMB.
Dated: November 3, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-24418 Filed 11-8-21; 8:45 am]
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