Agency Information Collection Activities: Proposed Collection; Comment Request, 42841-42843 [2021-16755]
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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
A. Covered Noncitizens
This Order applies to persons
traveling from Canada or Mexico
(regardless of their country of origin)
who would otherwise be introduced
into a congregate setting in a POE or
U.S. Border Patrol station at or near the
U.S. land and adjacent coastal borders
subject to certain exceptions detailed
below; this includes noncitizens who do
not have proper travel documents,
noncitizens whose entry is otherwise
contrary to law, and noncitizens who
are apprehended at or near the border
seeking to unlawfully enter the United
States between POE. For purposes of
this Order, I refer to persons covered by
the Order as ‘‘covered noncitizens.’’
B. Exceptions
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This Order does not apply to the
following:
• U.S. citizens, U.S. nationals, and
lawful permanent residents; 107
• Members of the armed forces of the
United States and associated personnel,
U.S. government employees or
contractors on orders abroad, or their
accompanying family members who are
on their orders or are members of their
household, subject to required
assurances; 108
• Noncitizens who hold valid travel
documents and arrive at a POE;
• Noncitizens in the visa waiver
program who are not otherwise subject
to travel restrictions and arrive at a POE;
• Unaccompanied Noncitizen
Children; 109
• Noncitizens who would otherwise
be subject to this Order, who are
permitted to enter the U.S. as part of a
DHS-approved process, where the
process approved by DHS has been
documented and shared with CDC, and
includes appropriate COVID–19
mitigation protocols, per CDC guidance;
and
• Persons whom customs officers
determine, with approval from a
supervisor, should be excepted from
this Order based on the totality of the
circumstances, including consideration
of significant law enforcement, officer
and public safety, humanitarian, and
public health interests. DHS will
consult with CDC regarding the
standards for such exceptions to help
ensure consistency with current CDC
CFR 71.40(f).
CFR 71.40(e)(1) and (3).
109 As excepted pursuant to the Public Health
Determination Regarding an Exception for
Unaccompanied Noncitizen Children from Order
Suspending the Right to Introduce Certain Persons
from Countries Where a Quarantinable
Communicable Disease Exists. 86 FR 38717 (July
22, 2021).
guidance and public health
recommendations.
C. APA, Review, and Termination
This Order shall be immediately
effective. I consulted with DHS and
other federal departments as needed
before I issued this Order and requested
that DHS continue to aid in the
enforcement of this Order because CDC
does not have the capability, resources,
or personnel needed to do so.110 As part
of the consultation, DHS developed
operational plans for implementing this
Order. CDC has reviewed these plans
and finds them to be consistent with the
language of this Order directing that
covered noncitizens spend as little time
in congregate settings as practicable
under the circumstances. In my view,
DHS’s assistance with implementing the
Order is necessary, as CDC’s other
public health tools are not viable
mechanisms given CDC resource and
personnel constraints, the large numbers
of covered noncitizens involved, and
the likelihood that covered noncitizens
do not have homes in the United
States.111
This Order is not a rule subject to
notice and comment under the
Administrative Procedure Act (APA).
Even if it were, notice and comment and
a delay in effective date are not required
because there is good cause to dispense
with prior public notice and the
opportunity to comment on this Order
and a delayed effective date. Given the
public health emergency caused by
COVID–19, it would be impracticable
and contrary to public health practices
and the public interest to delay the
issuing and effective date of this Order
with respect to all covered noncitizens.
In addition, this Order concerns ongoing
discussions with Canada and Mexico on
how best to control COVID–19
transmission over our shared borders
and therefore directly ‘‘involve[s] . . . a
. . . foreign affairs function of the
United States;’’ 112 thus, notice and
comment and a delay in effective date
are not required.
This Order shall remain effective until
either the expiration of the Secretary of
HHS’ declaration that COVID–19
constitutes a public health emergency,
or I determine that the danger of further
introduction, transmission, or spread of
COVID–19 into the United States has
ceased to be a serious danger to the
107 42
108 42
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110 42
U.S.C. 268; 42 CFR 71.40(d).
relies on the Department of Defense,
other federal agencies, and state and local
governments to provide both logistical support and
facilities for federal quarantines. CDC lacks the
resources, manpower, and facilities to quarantine
covered noncitizens.
112 5 U.S.C. 553(a)(1).
111 CDC
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42841
public health and continuation of this
Order is no longer necessary to protect
public health, whichever occurs first. At
least every 60 days, the CDC shall
review the latest information regarding
the status of the COVID–19 public
health emergency and associated public
health risks, including migration
patterns, sanitation concerns, and any
improvement or deterioration of
conditions at the U.S. border, to
determine whether the Order remains
necessary to protect public health. Upon
determining that the further
introduction of COVID–19 into the
United States is no longer a serious
danger to the public health necessitating
the continuation of this Order, I will
publish a notice in the Federal Register
terminating this Order. I retain the
authority to modify or terminate the
Order, or its implementation, at any
time as needed to protect public health.
Authority
The authority for this Order is
Sections 362 and 365 of the Public
Health Service Act (42 U.S.C. 265, 268)
and 42 CFR 71.40.
Dated: August 3, 2021.
Sherri Berger,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2021–16856 Filed 8–3–21; 4:15 pm]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10148 and CMS–
10784]
Agency Information Collection
Activities: Proposed Collection;
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 (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
SUMMARY:
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42842
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
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
October 4, 2021.
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, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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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–10148 HIPAA Administrative
Simplification (Non-Privacy/Security)
Complaint Form
CMS–10784 The Home Health Care
CAHPS® Survey (HHCAHPS) Mode
Experiment
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
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17:07 Aug 04, 2021
Jkt 253001
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: HIPAA
Administrative Simplification (NonPrivacy/Security) Complaint Form; Use:
The Secretary of Health and Human
Services (HHS), hereafter known as
‘‘The Secretary,’’ codified 45 CFR parts
160 and 164 Administrative
Simplification provisions that apply to
the enforcement of the Health Insurance
Portability and Accountability Act of
1996 Public Law 104–191 (HIPAA). The
provisions address rules relating to the
investigation of non-compliance of the
HIPAA Administrative Simplification
code sets, unique identifiers, operating
rules, and transactions. 45 CFR 160.306,
Complaints to the Secretary, provides
for investigations of covered entities by
the Secretary. Further, it outlines the
procedures and requirements for filing a
complaint against a covered entity.
Anyone can file a complaint if he or
she suspects a potential violation.
Persons believing that a covered entity
is not utilizing the adopted
Administrative Simplification
provisions of HIPAA are voluntarily
requested to file a complaint with CMS
via the Administrative Simplification
Enforcement and Testing Tool (ASETT)
online system, by mail, or by sending an
email to the HIPAA mailbox at
hipaacomplaint@cms.hhs.gov.
Information provided on the standard
form will be used during the
investigation process to validate noncompliance of HIPAA Administrative
Simplification provisions.
This standard form collects
identifying and contact information of
the complainant, as well as the
identifying and contact information of
the filed against entity (FAE). This
information enables CMS to respond to
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Fmt 4703
Sfmt 4703
the complainant and gather more
information if necessary, and to contact
the FAE to discuss the complaint and
CMS’ findings. Form Number: CMS–
10148 (OMB control number: 0938–
0948); Frequency: Occasionally;
Affected Public: Private sector, Business
or Not-for-profit institutions, State,
Local, or Tribal Governments, Federal
Government, Not-for-profits institutions;
Number of Respondents: 21; Total
Annual Responses: 21; Total Annual
Hours: 12. (For policy questions
regarding this collection contact Kevin
Stewart at 410–786–6149).
2. Type of Information Collection
Request: New collection (Request for a
new OMB control); Title of Information
Collection: The Home Health Care
CAHPS® Survey (HHCAHPS) Mode
Experiment; Use: The reporting of
quality data by HHAs is mandated by
Section 1895(b)(3)(B)(v)(II) of the Social
Security Act (‘‘the Act’’). This statute
requires that ‘‘each home health agency
shall submit to the Secretary such data
that the Secretary determines are
appropriate for the measurement of
health care quality. Such data shall be
submitted in a form and manner, and at
a time, specified by the Secretary for
purposes of this clause.’’ HHCAHPS
data are mandated in the Medicare
regulations at 42 CFR 484.250(a), which
requires HHAs to submit HHCAHPS
data to meet the quality reporting
requirements of section 1895(b)(3)(B)(v)
of the Act. This collection of
information is necessary to be able to
test updates to the HHCAHPS survey
and administration protocols.
CMS proposes to conduct a mode
experiment with the main goal of testing
the effects of a web-based mode on
response rates and scores as an addition
to the three currently approved modes
(OMB Control Number: 0938–1370). The
addition of a web mode will give HHAs
an alternative or an addition to the use
of mail and telephone modes. CMS is
also interested in testing a revised,
shorter version of the HHCAHPS survey,
based on feedback from patients and
stakeholders.
The data collected from the
HHCAHPS Survey mode experiment
will be used for the following purposes:
• Test the shortened survey
instrument, including several new
items;
• Compare survey responses across
the four proposed modes to determine if
adjustments are needed to ensure that
data collection mode does not influence
results; and
• Determine if and by how much
patient characteristics affect the
patients’ rating of the care they receive
E:\FR\FM\05AUN1.SGM
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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
and adjust results based on those
factors.
The mode experiment is designed to
examine the effects of the shortened
survey on response rates and scores and
to provide precise adjustment estimates
for survey items and composites on the
shortened survey instrument.
Information from this mode experiment
will help CMS determine whether an
additional mode of administration (i.e.,
Web data collection) should be included
and a shortened survey instrument
should be used in the current national
implementation of the HHCAHPS
Survey. Form Number: CMS–10784
(OMB control number: 0938–New);
Frequency: Annually; Affected Public:
Individuals or Households; Number of
Respondents: 6,280; Total Annual
Responses: 6,280; Total Annual Hours:
1,049. (For policy questions regarding
this collection contact Lori E. Teichman
at 410–786–6684).
Dated: August 2, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–16755 Filed 8–4–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0271]
Determination That VOTRIENT
(Pazopanib Hydrochloride) Tablets,
400 Milligrams, Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that VOTRIENT (pazopanib
hydrochloride) tablets, 400 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for pazopanib
hydrochloride tablets, 400 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Sungjoon Chi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6212,
Silver Spring, MD 20993–0002, 240–
402–9674, Sungjoon.Chi@fda.hhs.gov.
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SUMMARY:
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17:07 Aug 04, 2021
Jkt 253001
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, are the
subject of NDA 022465, held by
Novartis Pharmaceuticals Corp., and
initially approved on October 19, 2009.
VOTRIENT is a kinase inhibitor
indicated for the treatment of patients
with advanced renal cell carcinoma.
VOTRIENT (pazopanib hydrochloride)
tablets, 400 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
March 5, 2021 (Docket No. FDA–2021–
P–0271), under 21 CFR 10.30,
requesting that the Agency determine
whether VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
42843
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
VOTRIENT (pazopanib hydrochloride)
tablets, 400 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to VOTRIENT (pazopanib
hydrochloride) tablets, 400 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: July 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16692 Filed 8–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3741]
Remanufacturing of Medical Devices;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability; Extension of Comment
Period
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability; extension
of comment period.
AGENCY:
E:\FR\FM\05AUN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42841-42843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16755]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10148 and CMS-10784]
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
[[Page 42842]]
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 October 4, 2021.
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, you may make
your request using one of following:
1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
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 and associated
materials (see ADDRESSES).
CMS-10148 HIPAA Administrative Simplification (Non-Privacy/Security)
Complaint Form
CMS-10784 The Home Health Care CAHPS[supreg] Survey (HHCAHPS) Mode
Experiment
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: HIPAA
Administrative Simplification (Non-Privacy/Security) Complaint Form;
Use: The Secretary of Health and Human Services (HHS), hereafter known
as ``The Secretary,'' codified 45 CFR parts 160 and 164 Administrative
Simplification provisions that apply to the enforcement of the Health
Insurance Portability and Accountability Act of 1996 Public Law 104-191
(HIPAA). The provisions address rules relating to the investigation of
non-compliance of the HIPAA Administrative Simplification code sets,
unique identifiers, operating rules, and transactions. 45 CFR 160.306,
Complaints to the Secretary, provides for investigations of covered
entities by the Secretary. Further, it outlines the procedures and
requirements for filing a complaint against a covered entity.
Anyone can file a complaint if he or she suspects a potential
violation. Persons believing that a covered entity is not utilizing the
adopted Administrative Simplification provisions of HIPAA are
voluntarily requested to file a complaint with CMS via the
Administrative Simplification Enforcement and Testing Tool (ASETT)
online system, by mail, or by sending an email to the HIPAA mailbox at
[email protected]. Information provided on the standard form
will be used during the investigation process to validate non-
compliance of HIPAA Administrative Simplification provisions.
This standard form collects identifying and contact information of
the complainant, as well as the identifying and contact information of
the filed against entity (FAE). This information enables CMS to respond
to the complainant and gather more information if necessary, and to
contact the FAE to discuss the complaint and CMS' findings. Form
Number: CMS-10148 (OMB control number: 0938-0948); Frequency:
Occasionally; Affected Public: Private sector, Business or Not-for-
profit institutions, State, Local, or Tribal Governments, Federal
Government, Not-for-profits institutions; Number of Respondents: 21;
Total Annual Responses: 21; Total Annual Hours: 12. (For policy
questions regarding this collection contact Kevin Stewart at 410-786-
6149).
2. Type of Information Collection Request: New collection (Request
for a new OMB control); Title of Information Collection: The Home
Health Care CAHPS[supreg] Survey (HHCAHPS) Mode Experiment; Use: The
reporting of quality data by HHAs is mandated by Section
1895(b)(3)(B)(v)(II) of the Social Security Act (``the Act''). This
statute requires that ``each home health agency shall submit to the
Secretary such data that the Secretary determines are appropriate for
the measurement of health care quality. Such data shall be submitted in
a form and manner, and at a time, specified by the Secretary for
purposes of this clause.'' HHCAHPS data are mandated in the Medicare
regulations at 42 CFR 484.250(a), which requires HHAs to submit HHCAHPS
data to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act. This collection of information is
necessary to be able to test updates to the HHCAHPS survey and
administration protocols.
CMS proposes to conduct a mode experiment with the main goal of
testing the effects of a web-based mode on response rates and scores as
an addition to the three currently approved modes (OMB Control Number:
0938-1370). The addition of a web mode will give HHAs an alternative or
an addition to the use of mail and telephone modes. CMS is also
interested in testing a revised, shorter version of the HHCAHPS survey,
based on feedback from patients and stakeholders.
The data collected from the HHCAHPS Survey mode experiment will be
used for the following purposes:
Test the shortened survey instrument, including several
new items;
Compare survey responses across the four proposed modes to
determine if adjustments are needed to ensure that data collection mode
does not influence results; and
Determine if and by how much patient characteristics
affect the patients' rating of the care they receive
[[Page 42843]]
and adjust results based on those factors.
The mode experiment is designed to examine the effects of the
shortened survey on response rates and scores and to provide precise
adjustment estimates for survey items and composites on the shortened
survey instrument. Information from this mode experiment will help CMS
determine whether an additional mode of administration (i.e., Web data
collection) should be included and a shortened survey instrument should
be used in the current national implementation of the HHCAHPS Survey.
Form Number: CMS-10784 (OMB control number: 0938-New); Frequency:
Annually; Affected Public: Individuals or Households; Number of
Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours:
1,049. (For policy questions regarding this collection contact Lori E.
Teichman at 410-786-6684).
Dated: August 2, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-16755 Filed 8-4-21; 8:45 am]
BILLING CODE 4120-01-P
