Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request

CourtCenters For Medicare & Medicaid Services
Published date03 March 2022
Record Number2022-04445
12170
Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices
to Federal Maritime Commission, 800
North Capitol Street NW, Washington,
DC 20573–0001, and replies shall be
served on Petitioner’s counsel, Richard
D. Gluck, Foster Garvey PC, 1000
Potomac Street NW, Suite 200,
Washington, DC 20007, Richard.Gluck@
foster.com.
Non-confidential filings may be
submitted in hard copy to the Secretary
at the above address or by email as a
PDF attachment to Secretary@fmc.gov
and include in the subject line: P1–22
(Commenter/Company). Confidential
filings should not be filed by email. A
confidential filing must be filed with the
Secretary in hard copy only and be
accompanied by a transmittal letter that
identifies the filing as ‘‘Confidential-
Restricted’’ and describes the nature and
extent of the confidential treatment
requested. The Commission will
provide confidential treatment to the
extent allowed by law for confidential
submissions, or parts of submissions, for
which confidentiality has been
requested. When a confidential filing is
submitted, there must also be submitted
a public version of the filing. Such
public filing version shall exclude
confidential materials and shall indicate
on the cover page and on each affected
page ‘‘Confidential materials excluded.’’
Public versions of confidential filings
may be submitted by email. The Petition
will be posted on the Commission’s
website at http://www.fmc.gov/P1-22.
Replies filed in response to the Petition
will also be posted on the Commission’s
website at this location.
William Cody,
Secretary.
[FR Doc. 2022–04437 Filed 3–2–22; 8:45 am]
BILLING CODE 6730–02–P
FEDERAL MARITIME COMMISSION
Notice of Agreements Filed
The Commission hereby gives notice
of filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit
comments, relevant information, or
documents regarding the agreements to
the Secretary by email at Secretary@
fmc.gov, or by mail, Federal Maritime
Commission, 800 North Capitol Street,
Washington, DC 20573. Comments will
be most helpful to the Commission if
received within 12 days of the date this
notice appears in the Federal Register,
and the Commission requests that
comments be submitted within 7 days
on agreements that request expedited
review. Copies of agreements are
available through the Commission’s
website (www.fmc.gov) or by contacting
the Office of Agreements at (202) 523–
5793 or tradeanalysis@fmc.gov.
Agreement No.: 201379.
Agreement Name: Crowley/King
Ocean Dominican Republic/Haiti Space
Charter Agreement.
Parties: Crowley Latin America
Services, LLC and King Ocean Services
Limited, Inc.
Filing Party: Wayne Rohde; Cozen
O’Connor.
Synopsis: The Agreement authorizes
the parties to charter space to/from one
another on a space available/as used
basis in the trade between the U.S.
Atlantic Coast on the one hand and
ports in the Dominican Republic and
Haiti on the other hand.
Proposed Effective Date: 2/22/2022.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/59504.
Agreement No.: 201380.
Agreement Name: Crowley/Antillean
Dominican Republic/Haiti Space
Charter Agreement.
Parties: Antillean Marine Shipping
Corporation and Crowley Latin America
Services, LLC.
Filing Party: Wayne Rohde; Cozen
O’Connor.
Synopsis: The Agreement authorizes
the parties to charter space to/from one
another on a space available/as used
basis in the trade between the U.S.
Atlantic Coast on the one hand and
ports in the Dominican Republic and
Haiti on the other hand.
Proposed Effective Date: 2/24/2022.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/59505.
Agreement No.: 201356–002.
Agreement Name: PFLG/NPDL Slot
Charter Agreement.
Parties: Neptune Pacific Direct Line
Pte. Ltd. and Pacific Forum Line
(Group) Limited.
Filing Party: David Monroe; GKG Law.
Synopsis: The amendment updates
the amount of space being chartered
under the Agreement.
Proposed Effective Date: 2/17/2022.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/39510.
Agreement No.: 201378.
Agreement Name: NPDL/PFLG Slot
Charter Agreement.
Parties: Neptune Pacific Direct Line
Pte. Ltd. and Pacific Forum Line
(Group) Limited.
Filing Party: David Monroe; GKG Law.
Synopsis: The purpose of this
agreement is to allow NPDL to charter
space to PFLG in the relevant trades.
Proposed Effective Date: 2/17/2022.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/59502.
Dated: February 18, 2022.
William Cody,
Secretary.
[FR Doc. 2022–04436 Filed 3–2–22; 8:45 am]
BILLING CODE 6730–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10398 #64]
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
AGENCY
: Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION
: Notice.
SUMMARY
: On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. On October 23,
2011, OMB approved our initial request
to use the generic clearance process
under control number 0938–1148
(CMS–10398). It was last approved on
April 26, 2021, via the standard PRA
process which included the publication
of 60- and 30-day Federal Register
notices. The scope of the April 2021
umbrella accounts for Medicaid and
CHIP State plan amendments, waivers,
demonstrations, and reporting. This
Federal Register notice seeks public
comment on one or more of our
collection of information requests that
we believe are generic and fall within
the scope of the umbrella. Interested
persons are invited to submit 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
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12171
Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices
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
March 17, 2022.
ADDRESSES
: When commenting, please
reference the applicable form number
(see below) and the OMB control
number (0938–1148). 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 http://
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: CMS–10398 (#64)/OMB
control number: 0938–1148, 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 access CMS’
website 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
: Following
is a summary of the use and burden
associated with the subject information
collection(s). More detailed information
can be found in the collection’s
supporting statement and associated
materials (see
ADDRESSES
).
Generic Information Collection
1. Title of Information Collection:
Medicaid Section 1115 Substance Use
Disorder (SUD) Demonstration: Federal
Meta-Analysis Support; Type of
Information Collection Request:
Revision of a currently approved
collection; Use: Starting in 2015, in
response to the opioid epidemic, CMS
offered states the flexibility to test
Medicaid coverage of a full substance
use disorder (SUD) treatment service
array in the context of overall SUD
service delivery transformation through
the authority of section 1115
demonstrations. In 2017, CMS modified
the requirements for SUD section 1115
demonstrations to improve access to
clinically appropriate treatment for
OUD and other SUDs, to better support
the development and expansion of
comprehensive treatment strategies, and
to incorporate improved progress and
outcome monitoring. In 2018, CMS
awarded the Federal Meta-Analysis
Support contract to RTI International to
understand the overall effectiveness of
the groups of demonstrations with
similar features and how variations in
state demonstration features and the
context in which they are implemented
contribute to differences in
effectiveness. The meta-analysis
includes multiple rounds of qualitative
data collection. The first round of
interviews (both, Characteristics
Interviews and Implementation
Interviews) have been completed. This
March 2022 collection of information
request seeks OMB’s approval for a
second round (State-level Stakeholder
Virtual Interviews) of data collection
activities. The purpose is to learn about
the perspectives of other types of
stakeholders important to implementing
the demonstration. Respondents would
include stakeholders with differing
perspectives, including leadership of
behavioral health service providers and
leadership of MCOs or third-party
administrators in states with fee-for-
service SUD treatment services. Form
Number: CMS–10398 (#64) (OMB
control number: 0938–1148); Frequency:
Once; Affected Public: State, Local, or
Tribal Governments, and the Private
sector; Number of Respondents: 90;
Total Annual Responses: 90; Total
Annual Hours: 83. (For policy questions
regarding this collection contact:
Danielle Daly at 410–786–0897.)
Dated: February 28, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–04445 Filed 3–2–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0964]
Eduardo Navarro: Final Debarment
Order
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Eduardo
Navarro from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Navarro was convicted
of a felony under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of any drug
product under the FD&C Act. Mr.
Navarro was given notice of the
proposed permanent debarment and
was given an opportunity to request a
hearing to show why he should not be
debarred. As of December 24, 2021 (30
days after receipt of the notice), Mr.
Navarro had not responded. Mr.
Navarro’s failure to respond and request
a hearing within the prescribed
timeframe constitutes a waiver of his
right to a hearing concerning this action.
DATES
: This order is applicable March 3,
2022.
ADDRESSES
: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT
:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
I. Background
Section 306(a)(2)(A) of the FD&C Act
(21 U.S.C. 335a(a)(2)(A)) requires
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
drug product application if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the development or
approval, including the process of
development or approval, of any drug
product under the FD&C Act. On August
11, 2021, Mr. Navarro was convicted as
defined in section 306(l)(1) of the FD&C
Act in the U.S. District Court for the
Southern District of Florida, Miami
Division, when the court accepted his
plea of guilty and entered judgment
against him for one count of Conspiracy
to Defraud the United States in violation
of 18 U.S.C. 371.
The factual basis for this conviction is
as follows: As contained in the
Information, entered into the docket on
March 16, 2021, and the Factual Proffer
in Support of his guilty plea, entered
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