Agency Information Collection Activities: Submission for OMB Review; Comment Request, 67464-67466 [2019-26595]
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Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/
EXCLUSION CRITERIA—Continued
PICOTS
Inclusion
Exclusion
Æ Harms specific to pregnancy and breastfeeding (infertility,
miscarriage,
abruption,
preterm
labor/preterm
birth,
preeclampsia, gestational hypertensive disorders, glucose intolerance/gestational diabetes mellitus, reduced milk production in breastfeeding/undesired weaning).
Æ Danger to self or infant.
Æ Misuse of prescription medication.
Æ Serious adverse events related to treatment.
Æ Death.
• Fetal/infant/child harms.
Æ Preterm birth/small for gestational age or large for gestational
age.
Æ Congenital anomalies.
Æ Perinatal complications (low APGAR, withdrawal, respiratory
distress, neonatal intensive care unit time, persistent pulmonary hypertension).
Æ Poor infant attachment/bonding *†.
Æ Delayed social, emotional, and cognitive development *.
Æ Death.
Time frame ...
Followup .......................................................................................................
KQ 1, KQ 2: From conception up to 1 year postpartum for maternal outcomes.
KQ 3, KQ 4: All ............................................................................................
Followup
• KQ 1, KQ 2: More than 12 weeks preconception for maternal preconception outcomes, more than 1 year for maternal postpartum outcomes
• KQ 3, KQ 4: None.
Settings § .....
Clinical setting ..............................................................................................
All settings ....................................................................................................
Clinical setting
None.
Study design
• RCTs, CCTs, case-control studies, cohort studies with comparison
arms.
• Reference lists of relevant systematic reviews published in 2013 or
later will be used to ensure our search strategies captured all relevant
studies.
All other designs and studies using included designs that do not meet the
sample size criterion.
Language .....
Studies published in English ........................................................................
Studies published in languages other than English.
* We will limit included outcomes to those using validated measures. Another potential exclusion, depending on volume of yield, includes studies that fail to control
for confounding.
† Drugs such as brexanolone that are awaiting FDA approval will be included in the review once they are approved
‡ We will focus strength of evidence (SOE) grades on outcomes prioritized by the Technical Expert Panel (TEP).
§ Depending on volume, we may limit the primary analysis to studies from geographic settings with resources comparable or applicable to the United States.
Dated: December 4, 2019.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019–26510 Filed 12–9–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
jbell on DSKJLSW7X2PROD with NOTICES
Statement of Organization, Functions,
and Delegations of Authority
Part J (Agency for Toxic Substances
and Disease Registry) of the Statement
of Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (50 FR 25129–25130, dated
June 17, 1985, as amended most
recently at 82 FR 42555, dated
September 8, 2017) is amended to
reflect the Order of Succession for the
Agency for Toxic Substances and
Disease Registry.
Section J–C, Order of Succession:
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17:49 Dec 09, 2019
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Delete in its entirety the Section J–C,
Order of Succession, and insert the
following:
During the absence or disability of the
Administrator, Agency for Toxic
Substances and Disease Registry
(ATSDR), or in the event of a vacancy
in that office, the first official listed
below who is available shall act as
Administrator, except during a planned
period of absence, the Administrator
may specify a different order of
succession:
1. Assistant Administrator, ATSDR
2. Deputy Director for Non-Infectious
Diseases
3. Principal Deputy Director
4. Chief Medical Officer
5. Director, Center for Preparedness and
Response
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–26494 Filed 12–9–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10221, CMS–
10344 and CMS–10137]
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
SUMMARY:
E:\FR\FM\10DEN1.SGM
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
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 January 9, 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
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
VerDate Sep<11>2014
17:08 Dec 09, 2019
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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: Reinstatement without change
of a previously approved collection;
Title of Information Collection:
Independent Diagnostic Testing
Facilities (IDTFs) Site Investigation
Form Revisions; Use: The data
collection is used by Medicare
contractors and/or their subcontractors
on site visits to verify compliance with
required IDTF performance standards. If
a subcontractor is used, the
subcontractor collects the information
from the IDTF through an interview and
forwards it to the Medicare contractor
for evaluation.
The collection and verification of this
information defends and protects our
beneficiaries from illegitimate IDTFs.
These procedures also protect the
Medicare Trust Fund against fraud. The
data collected also ensures that the
applicant has the necessary credentials
to provide the health care services for
which they intend to bill Medicare.
Form Number: CMS–10221 (OMB
control number: 0938–1029); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profit and
Not-for-profit institutions); Number of
Respondents: 727; Total Annual
Responses: 727; Total Annual Hours:
1,454. (For policy questions regarding
this collection contact Kimberly
McPhillips at 410–786–5374.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Elimination of
Cost-Sharing for full benefit dualeligible Individuals Receiving Home
and Community-Based Services; Use:
Each month CMS deems individuals
automatically eligible for the full
subsidy, based on data from State
Medicaid Agencies and the Social
Security Administration (SSA). The
SSA sends a monthly file of
Supplementary Security Income-eligible
beneficiaries to CMS. Similarly, the
State Medicaid agencies submit
Medicare Modernization Act files to
CMS that identify full subsidy
beneficiaries. CMS deems the
beneficiaries as having full subsidy and
auto-assigns these beneficiaries to bench
mark Part D plans. Part D plans receive
premium amounts based on the monthly
assessments.
State MMA Phase Down (SPD)
exchange enables CMS to implement the
Medicare Prescription Drug,
Improvement, and Modernization Act,
also called the Medicare Modernization
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Act (MMA), which was enacted into law
in 2003. This data exchange allows the
State Medicaid Agency (SMA) to
identify Medicare beneficiaries with
coverage under the Medicaid program.
The SMAs also identify other lowincome Medicare beneficiaries who
have applied for the Part D Low-Income
Subsidy (LIS). As a result of the
identification of these two groups of
beneficiaries, CMS auto-assigns and/or
facilitates enrollment of the appropriate
beneficiaries into Part D plans.
Section 1860 D–14 of the Social
Security Act sets forth requirements for
premium and cost-sharing subsidies for
low-income beneficiaries enrolled in
Medicare Part D. Based on this statute,
42 CFR 423.771, provides guidance
concerning limitations for payments
made by and on behalf of low-income
Medicare beneficiaries who enroll in
Part D plans. 42 CFR 423.771 (b)
establishes requirements for
determining a beneficiary’s eligibility
for full subsidy under the Part D
program. Regulations set forth in
423.780 and 423.782 outline premium
and cost sharing subsidies to which full
subsidy eligible are entitled under the
Part D program. Form Number: CMS–
10344 (OMB control number: 0938–
1127); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 612; Total
Annual Hours: 612. (For policy
questions regarding this collection
contact Roland O. Herrera at 410–786–
0668.)
3. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Title
Solicitation for Applications for
Medicare Prescription Drug Plan 2021
Contracts; Use: Coverage for the
prescription drug benefit is provided
through contracted prescription drug
plans (PDPs) or through Medicare
Advantage (MA) plans that offer
integrated prescription drug and health
care coverage (MA–PD plans). Cost
Plans that are regulated under Section
1876 of the Social Security Act, and
Employer Group Waiver Plans (EGWP)
may also provide a Part D benefit.
Organizations wishing to provide
services under the Prescription Drug
Benefit Program must complete an
application, negotiate rates, and receive
final approval from CMS. Existing Part
D Sponsors may also expand their
contracted service area by completing
the Service Area Expansion (SAE)
application.
Collection of this information is
mandated in Part D of the Medicare
Prescription Drug, Improvement, and
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Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
Modernization Act of 2003 (MMA) in
Subpart 3. The application requirements
are codified in Subpart K of 42 CFR 423
entitled ‘‘Application Procedures and
Contracts with PDP Sponsors.’’
The information will be collected
under the solicitation of proposals from
PDP, MA–PD, Cost Plan, Program of All
Inclusive Care for the Elderly (PACE),
and EGWP applicants. The collected
information will be used by CMS to: (1)
Ensure that applicants meet CMS
requirements for offering Part D plans
(including network adequacy,
contracting requirements, and
compliance program requirements, as
described in the application), (2)
support the determination of contract
awards. Form Number: CMS–10137
(OMB control number: 0938–0936);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 243; Total
Annual Responses: 290; Total Annual
Hours: 1,384.79. (For policy questions
regarding this collection contact
Arianne Spaccarelli at 410–786–5715.)
Dated: December 5, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–26595 Filed 12–9–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/–304a and
CMS–368/–R–144]
Agency Information Collection
Activities: Proposed Collection;
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 (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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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17:08 Dec 09, 2019
Jkt 250001
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
February 10, 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 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 the 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:
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–304/–304a Reconciliation of
State Invoice and Prior Quarter
Adjustment Statement
CMS–368/–R–144 Medicaid Drug
Rebate Program Forms
PO 00000
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Sfmt 4703
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: 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.)
2. 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
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]]>Agencies
[Federal Register Volume 84, Number 237 (Tuesday, December 10, 2019)]
[Notices]
[Pages 67464-67466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26595]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10221, CMS-10344 and CMS-10137]
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
[[Page 67465]]
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 January 9, 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 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: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Independent Diagnostic Testing Facilities (IDTFs) Site
Investigation Form Revisions; Use: The data collection is used by
Medicare contractors and/or their subcontractors on site visits to
verify compliance with required IDTF performance standards. If a
subcontractor is used, the subcontractor collects the information from
the IDTF through an interview and forwards it to the Medicare
contractor for evaluation.
The collection and verification of this information defends and
protects our beneficiaries from illegitimate IDTFs. These procedures
also protect the Medicare Trust Fund against fraud. The data collected
also ensures that the applicant has the necessary credentials to
provide the health care services for which they intend to bill
Medicare. Form Number: CMS-10221 (OMB control number: 0938-1029);
Frequency: Occasionally; Affected Public: Private Sector (Business or
other for-profit and Not-for-profit institutions); Number of
Respondents: 727; Total Annual Responses: 727; Total Annual Hours:
1,454. (For policy questions regarding this collection contact Kimberly
McPhillips at 410-786-5374.)
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Elimination of Cost-Sharing for full benefit dual-eligible Individuals
Receiving Home and Community-Based Services; Use: Each month CMS deems
individuals automatically eligible for the full subsidy, based on data
from State Medicaid Agencies and the Social Security Administration
(SSA). The SSA sends a monthly file of Supplementary Security Income-
eligible beneficiaries to CMS. Similarly, the State Medicaid agencies
submit Medicare Modernization Act files to CMS that identify full
subsidy beneficiaries. CMS deems the beneficiaries as having full
subsidy and auto-assigns these beneficiaries to bench mark Part D
plans. Part D plans receive premium amounts based on the monthly
assessments.
State MMA Phase Down (SPD) exchange enables CMS to implement the
Medicare Prescription Drug, Improvement, and Modernization Act, also
called the Medicare Modernization Act (MMA), which was enacted into law
in 2003. This data exchange allows the State Medicaid Agency (SMA) to
identify Medicare beneficiaries with coverage under the Medicaid
program. The SMAs also identify other low-income Medicare beneficiaries
who have applied for the Part D Low-Income Subsidy (LIS). As a result
of the identification of these two groups of beneficiaries, CMS auto-
assigns and/or facilitates enrollment of the appropriate beneficiaries
into Part D plans.
Section 1860 D-14 of the Social Security Act sets forth
requirements for premium and cost-sharing subsidies for low-income
beneficiaries enrolled in Medicare Part D. Based on this statute, 42
CFR 423.771, provides guidance concerning limitations for payments made
by and on behalf of low-income Medicare beneficiaries who enroll in
Part D plans. 42 CFR 423.771 (b) establishes requirements for
determining a beneficiary's eligibility for full subsidy under the Part
D program. Regulations set forth in 423.780 and 423.782 outline premium
and cost sharing subsidies to which full subsidy eligible are entitled
under the Part D program. Form Number: CMS-10344 (OMB control number:
0938-1127); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 51; Total Annual Responses: 612;
Total Annual Hours: 612. (For policy questions regarding this
collection contact Roland O. Herrera at 410-786-0668.)
3. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection: Title
Solicitation for Applications for Medicare Prescription Drug Plan 2021
Contracts; Use: Coverage for the prescription drug benefit is provided
through contracted prescription drug plans (PDPs) or through Medicare
Advantage (MA) plans that offer integrated prescription drug and health
care coverage (MA-PD plans). Cost Plans that are regulated under
Section 1876 of the Social Security Act, and Employer Group Waiver
Plans (EGWP) may also provide a Part D benefit. Organizations wishing
to provide services under the Prescription Drug Benefit Program must
complete an application, negotiate rates, and receive final approval
from CMS. Existing Part D Sponsors may also expand their contracted
service area by completing the Service Area Expansion (SAE)
application.
Collection of this information is mandated in Part D of the
Medicare Prescription Drug, Improvement, and
[[Page 67466]]
Modernization Act of 2003 (MMA) in Subpart 3. The application
requirements are codified in Subpart K of 42 CFR 423 entitled
``Application Procedures and Contracts with PDP Sponsors.''
The information will be collected under the solicitation of
proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for
the Elderly (PACE), and EGWP applicants. The collected information will
be used by CMS to: (1) Ensure that applicants meet CMS requirements for
offering Part D plans (including network adequacy, contracting
requirements, and compliance program requirements, as described in the
application), (2) support the determination of contract awards. Form
Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 243; Total Annual Responses: 290; Total Annual Hours:
1,384.79. (For policy questions regarding this collection contact
Arianne Spaccarelli at 410-786-5715.)
Dated: December 5, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-26595 Filed 12-9-19; 8:45 am]
BILLING CODE 4120-01-P
