Agency Information Collection Activities: Proposed Collection; Comment Request, 86905-86906 [2023-27614]
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Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices
purposes of publication in the Federal
Register.
Dated: December 12, 2023.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–27551 Filed 12–14–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/–304a,
CMS–368/–R–144, and CMS–10249]
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
(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
February 13, 2024.
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
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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, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
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 (ROSI) (CMS–304) and
Prior Quarter Adjustment Statement
(PQAS) (CMS–304a)
CMS–368/–R–144 State Agency
Contact Form (CMS–368) and
Quarterly State Invoice (CMS–R–144)
CMS–10249 Administrative
Requirements for Section 6071 of the
Deficit Reduction Act
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.
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86905
Information Collection
1. Type of Information Collection
Request: Extension 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: Private
sector (business or other for-profits);
Number of Respondents: 749; Total
Annual Responses: 5,841; Total Annual
Hours: 248,584. (For policy questions
regarding this collection contact Robert
Giles at 667–290–8626.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program State Reporting Forms;
Use: Form CMS 368 is a report of
contact for the State to name the
individuals involved in the Medicaid
Drug Rebate Program (MDRP) and is
required only in those instances where
a change to the originally submitted
data is necessary. The ability to require
the reporting of any changes to these
data is necessary to the efficient
operation of these programs. Form
CMS–R–144 is required from States
quarterly to report utilization for any
drugs paid for during that quarter. 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: 290; Total
Annual Hours: 13,669. (For policy
questions regarding this collection
contact Robert Giles at 667–290–8626.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Administrative
Requirements for Section 6071 of the
Deficit Reduction Act; Use: State
Operational Protocols should provide
enough information such that: the CMS
Project Officer and other Federal
officials may use it to understand the
operation of the demonstration, prepare
for potential site visits without needing
additional information, or both; the
State Project Director can use it as the
manual for program implementation;
and external stakeholders may use it to
understand the operation of the
demonstration. The financial
E:\FR\FM\15DEN1.SGM
15DEN1
86906
Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices
information collection is used in our
financial statements and shared with the
auditors who validate CMS’ financial
position. The Money Follows the Person
Rebalancing Demonstration (MFP)
Finders File, MFP Program Participation
Data file, and MFP Services File are
used by the national evaluation
contractor to assess program outcomes
while we use the information to monitor
program implementation. The MFP
Quality of Life data is used by the
national evaluation contractor to assess
program outcomes. The evaluation is
used to determine how participants’
quality of life changes after transitioning
to the community. The semi-annual
progress report is used by the national
evaluation contractor and CMS to
monitor program implementation at the
grantee level. Form Number: CMS–
10249 (OMB control number: 0938–
1053); Frequency: Yearly, quarterly, and
semi-annually; Affected Public: State,
local, or Tribal governments; Number of
Respondents: 41; Total Annual
Responses: 410; Total Annual Hours:
4,326. (For policy questions regarding
this collection contact Alicia Ryce at
410–786–1075.)
Dated: December 12, 2023.
William N. Parham, III
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–27614 Filed 12–14–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3369]
Adam Michael Nagy: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Adam Michael Nagy for a period of 15
years from importing or offering for
import any drug into the United States.
FDA bases this order on a finding that
Mr. Nagy was convicted of three
relevant felony counts under Federal
law. The factual basis supporting Mr.
Nagy’s conviction, as described below,
is conduct relating to the importation
into the United States of a drug or
controlled substance. Mr. Nagy was
given notice of the proposed debarment
and was given an opportunity to request
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a hearing to show why he should not be
debarred. As of October 22, 2023 (30
days after receipt of the notice), Mr.
Nagy had not responded. Mr. Nagy’s
failure to respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is effective December
15, 2023.
ADDRESSES: Any application by Mr.
Nagy for termination of debarment
under section 306(d)(1) of the FD&C Act
(21 U.S.C. 335a(d)(1)) may be submitted
as follows:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
application, that information will be
posted on https://www.regulations.gov.
• If you want to submit an
application with confidential
information that you do not wish to be
made available to the public, submit the
application as a written/paper
submission and in the manner detailed
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
Written/Paper Submissions
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All applications must
include the Docket No. FDA–2023–N–
3369. Received applications will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
• Confidential Submissions—To
submit an application with confidential
information that you do not wish to be
made publicly available, submit your
application only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of your application.
The second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. Any information marked as
‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to
https://www.regulations.gov and insert
the docket number, found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852 between 9 a.m.
and 4 p.m., Monday through Friday.
Publicly available submissions may be
seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, at 240–402–8743, or
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if the FDA
finds, as required by section 306(b)(3)(C)
of the FD&C Act, that the individual has
been convicted of a felony for conduct
relating to the importation into the
United States of any drug or controlled
substance.
On May 1, 2023, Mr. Nagy was
convicted, as defined in section
306(l)(1) of FD&C Act, in the U.S.
District Court for the Western District of
Pennsylvania, when the court entered
judgment against him for multiple
E:\FR\FM\15DEN1.SGM
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Agencies
[Federal Register Volume 88, Number 240 (Friday, December 15, 2023)]
[Notices]
[Pages 86905-86906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27614]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-304/-304a, CMS-368/-R-144, and CMS-10249]
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 (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 February 13, 2024.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
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 (ROSI) (CMS-304) and
Prior Quarter Adjustment Statement (PQAS) (CMS-304a)
CMS-368/-R-144 State Agency Contact Form (CMS-368) and Quarterly State
Invoice (CMS-R-144)
CMS-10249 Administrative Requirements for Section 6071 of the Deficit
Reduction Act
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: 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: Private sector (business or other for-profits); Number of
Respondents: 749; Total Annual Responses: 5,841; Total Annual Hours:
248,584. (For policy questions regarding this collection contact Robert
Giles at 667-290-8626.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate Program State Reporting Forms; Use: Form CMS 368 is a report of
contact for the State to name the individuals involved in the Medicaid
Drug Rebate Program (MDRP) and is required only in those instances
where a change to the originally submitted data is necessary. The
ability to require the reporting of any changes to these data is
necessary to the efficient operation of these programs. Form CMS-R-144
is required from States quarterly to report utilization for any drugs
paid for during that quarter. 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: 290; Total Annual Hours:
13,669. (For policy questions regarding this collection contact Robert
Giles at 667-290-8626.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Administrative
Requirements for Section 6071 of the Deficit Reduction Act; Use: State
Operational Protocols should provide enough information such that: the
CMS Project Officer and other Federal officials may use it to
understand the operation of the demonstration, prepare for potential
site visits without needing additional information, or both; the State
Project Director can use it as the manual for program implementation;
and external stakeholders may use it to understand the operation of the
demonstration. The financial
[[Page 86906]]
information collection is used in our financial statements and shared
with the auditors who validate CMS' financial position. The Money
Follows the Person Rebalancing Demonstration (MFP) Finders File, MFP
Program Participation Data file, and MFP Services File are used by the
national evaluation contractor to assess program outcomes while we use
the information to monitor program implementation. The MFP Quality of
Life data is used by the national evaluation contractor to assess
program outcomes. The evaluation is used to determine how participants'
quality of life changes after transitioning to the community. The semi-
annual progress report is used by the national evaluation contractor
and CMS to monitor program implementation at the grantee level. Form
Number: CMS-10249 (OMB control number: 0938-1053); Frequency: Yearly,
quarterly, and semi-annually; Affected Public: State, local, or Tribal
governments; Number of Respondents: 41; Total Annual Responses: 410;
Total Annual Hours: 4,326. (For policy questions regarding this
collection contact Alicia Ryce at 410-786-1075.)
Dated: December 12, 2023.
William N. Parham, III
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-27614 Filed 12-14-23; 8:45 am]
BILLING CODE 4120-01-P