Agency Information Collection Activities: Submission for OMB Review; Comment Request, 13163-13164 [2020-04607]
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lotter on DSKBCFDHB2PROD with NOTICES
Federal Register / Vol. 85, No. 45 / Friday, March 6, 2020 / Notices
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
May 5, 2020.
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
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:31 Mar 05, 2020
Jkt 250001
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–10275
Survey
CAHPS Home Health Care
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 without change of a
currently approved collection; Title of
Information Collection: CAHPS Home
Health Care Survey; Use: The national
implementation of the Home Health
Care CAHPS Survey is designed to
collect ongoing data from samples of
home health care patients who receive
skilled services from Medicare-certified
home health agencies.
The survey is necessary because it
fulfills the goal of transparency with the
public about home health patient
experiences. The survey is used by
Medicare-certified home health agencies
to improve their internal quality
assurance in the care that they provide
in home health. The HHCAHPS survey
is also used in a Medicare payment
program. Medicare-certified home
health agencies (HHAs) must contract
with CMS-approved survey vendors that
conduct the HHCAHPS on behalf of the
HHAs to meet their requirements in the
Home Health Quality Reporting
Program. Form Number: CMS–10257
(OMB control number: 0938–1066);
Frequency: Yearly; Affected Public:
Individuals and Households; Number of
Respondents: 1,195,930; Total Annual
Responses: 1,294,820; Total Annual
Hours: 453,239. (For policy questions
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
13163
regarding this collection contact Lori
Teichman at 410- 786–6684.)
Dated: March 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–04612 Filed 3–5–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10718, CMS–
304/–304a and CMS–368/–R–144]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid 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 April 6, 2020.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
DATES:
E:\FR\FM\06MRN1.SGM
06MRN1
lotter on DSKBCFDHB2PROD with NOTICES
13164
Federal Register / Vol. 85, No. 45 / Friday, March 6, 2020 / Notices
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
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.
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. Call the Reports Clearance Office at
(410) 786–1326.
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: New collection; Title of
Information Collection: Model Medicare
Advantage and Medicare Prescription
Drug Plan Individual Enrollment
Request Form; Use: This information
collection is necessary for the Medicare
beneficiary (or their legal
representative), to enroll in an MA or
PDP plan, even if switching plans
within the same MA or PDP
organization. To consider an election
complete, the individual must:
• Complete an enrollment request;
• Provide required information to the
MA or PDP organization within the
required time frames;
• Submit the completed request to the
MA or PDP organization during a valid
enrollment period.
• MA and PDP organizations,
applicants to MA and PDP
VerDate Sep<11>2014
18:31 Mar 05, 2020
Jkt 250001
organizations, and the CMS will use the
information collected to comply with
the eligibility and enrollment
requirements for Medicare Part C and
Part D plans.
Section 4001 of the Balanced Budget
Act of 1997 (BBA) (Pub. L. 105–33)
enacted August 5, 1997, established Part
C of the Medicare program, known as
the Medicare + Choice program, (now
referred to as Medicare Advantage
(MA)). As required by 42 CFR
422.50(a)(5), an MA-eligible individual
who meets the eligibility requirements
for enrollment into an MA or MAPD
plan may enroll during the enrollment
periods specified in § 422.62, by
completing an enrollment form with the
MA organization or enrolling through
other mechanisms that CMS determines
are appropriate.
Section 101 of Title I of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) enacted December 8, 2003,
established Part D of the Medicare
program, known as the Voluntary
Prescription Drug Benefit Program. As
required by 42 CFR 423.32(a) and (b), a
Part D-eligible individual who wishes to
enroll in a Medicare prescription drug
plan (PDP) may enroll during the
enrollment periods specified in
§ 423.38, by completing an enrollment
form with the PDP, or enrolling through
other mechanisms CMS determines are
appropriate. Form Number: CMS–10718
(OMB control number: 0938–New);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 14,749,256;
Total Annual Responses: 14,749,256;
Total Annual Hours: 7,861,354. (For
policy questions regarding this
collection contact Deme Umo at (410)
786–8854.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Reconciliation
of State Invoice (ROSI) and Prior
Quarter Adjustment Statement (PQAS);
Use: Form CMS–304 (ROSI) is used by
manufacturers to respond to the state’s
rebate invoice for current quarter
utilization. Form CMS–304a (PQAS) is
required only in those instances where
a change to the original rebate data
submittal is necessary. Form Number:
CMS–304 and –304a (OMB control
number: 0938–0676); Frequency:
Quarterly; Affected Public: Business or
other for-profits; Number of
Respondents: 1,255; Total Annual
Responses: 5,020; Total Annual Hours:
227,416. (For policy questions regarding
this collection contact Andrea
Wellington at 410–786–3490.)
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate State Reporting Program Forms;
Use: We develop the rebate amount per
drug unit from information supplied by
the drug manufacturers and distributes
these data to the states. States then must
report quarterly to the drug
manufacturers and report to us the total
number of units of each dosage form/
strength of their covered outpatient
drugs reimbursed during a quarter and
the rebate amount to be refunded. This
report is due within 60 days of the end
of each calendar quarter. The
information in the report is based on
claims paid by the state Medicaid
agency during a calendar quarter. Form
CMS–R–144 (Quarterly Report Data) is
required from states quarterly to report
utilization for any drugs paid for during
that quarter. Form CMS–368
(Administrative Data) is required only
in those instances where a change to the
original data submittal is necessary.
Form Number: CMS–368 and –R–144
(OMB control number: 0938–0582);
Frequency: Quarterly and on occasion;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 234; Total
Annual Hours: 12,101. (For policy
questions regarding this collection
contact Shannon Evans at 410–786–
3083.)
Dated: March 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–04607 Filed 3–5–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0179]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency)
Center for Drug Evaluation and Research
(CDER) is announcing the continuation
of the Regulatory Project Management
Site Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
SUMMARY:
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13163-13164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04607]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10718, CMS-304/-304a and CMS-368/-R-144]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid 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 April 6, 2020.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax
[[Page 13164]]
Number: (202) 395-5806 OR, Email: [email protected].
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.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. Call the Reports Clearance Office at (410) 786-1326.
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: New collection; Title of
Information Collection: Model Medicare Advantage and Medicare
Prescription Drug Plan Individual Enrollment Request Form; Use: This
information collection is necessary for the Medicare beneficiary (or
their legal representative), to enroll in an MA or PDP plan, even if
switching plans within the same MA or PDP organization. To consider an
election complete, the individual must:
Complete an enrollment request;
Provide required information to the MA or PDP organization
within the required time frames;
Submit the completed request to the MA or PDP organization
during a valid enrollment period.
MA and PDP organizations, applicants to MA and PDP
organizations, and the CMS will use the information collected to comply
with the eligibility and enrollment requirements for Medicare Part C
and Part D plans.
Section 4001 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-
33) enacted August 5, 1997, established Part C of the Medicare program,
known as the Medicare + Choice program, (now referred to as Medicare
Advantage (MA)). As required by 42 CFR 422.50(a)(5), an MA-eligible
individual who meets the eligibility requirements for enrollment into
an MA or MAPD plan may enroll during the enrollment periods specified
in Sec. 422.62, by completing an enrollment form with the MA
organization or enrolling through other mechanisms that CMS determines
are appropriate.
Section 101 of Title I of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173)
enacted December 8, 2003, established Part D of the Medicare program,
known as the Voluntary Prescription Drug Benefit Program. As required
by 42 CFR 423.32(a) and (b), a Part D-eligible individual who wishes to
enroll in a Medicare prescription drug plan (PDP) may enroll during the
enrollment periods specified in Sec. 423.38, by completing an
enrollment form with the PDP, or enrolling through other mechanisms CMS
determines are appropriate. Form Number: CMS-10718 (OMB control number:
0938-New); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 14,749,256; Total Annual Responses:
14,749,256; Total Annual Hours: 7,861,354. (For policy questions
regarding this collection contact Deme Umo at (410) 786-8854.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Reconciliation of
State Invoice (ROSI) and Prior Quarter Adjustment Statement (PQAS);
Use: Form CMS-304 (ROSI) is used by manufacturers to respond to the
state's rebate invoice for current quarter utilization. Form CMS-304a
(PQAS) is required only in those instances where a change to the
original rebate data submittal is necessary. Form Number: CMS-304 and -
304a (OMB control number: 0938-0676); Frequency: Quarterly; Affected
Public: Business or other for-profits; Number of Respondents: 1,255;
Total Annual Responses: 5,020; Total Annual Hours: 227,416. (For policy
questions regarding this collection contact Andrea Wellington at 410-
786-3490.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate State Reporting Program Forms; Use: We develop the rebate amount
per drug unit from information supplied by the drug manufacturers and
distributes these data to the states. States then must report quarterly
to the drug manufacturers and report to us the total number of units of
each dosage form/strength of their covered outpatient drugs reimbursed
during a quarter and the rebate amount to be refunded. This report is
due within 60 days of the end of each calendar quarter. The information
in the report is based on claims paid by the state Medicaid agency
during a calendar quarter. Form CMS-R-144 (Quarterly Report Data) is
required from states quarterly to report utilization for any drugs paid
for during that quarter. Form CMS-368 (Administrative Data) is required
only in those instances where a change to the original data submittal
is necessary. Form Number: CMS-368 and -R-144 (OMB control number:
0938-0582); Frequency: Quarterly and on occasion; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 56; Total
Annual Responses: 234; Total Annual Hours: 12,101. (For policy
questions regarding this collection contact Shannon Evans at 410-786-
3083.)
Dated: March 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-04607 Filed 3-5-20; 8:45 am]
BILLING CODE 4120-01-P
