Agency Information Collection Activities: Proposed Collection; Comment Request, 86905-86906 [2023-27614]

Download as PDF 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:57 Dec 14, 2023 Jkt 262001 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. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:57 Dec 14, 2023 Jkt 262001 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 15DEN1

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]


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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
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