Agency Information Collection Activities: Proposed Collection; Comment Request, 12844-12845 [2024-03348]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 12844 Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices one member shall be a specialist in the rural aspects of one or more of the professions or fields listed below. In addition, the Secretary designates, as ex officio members, representatives from other Federal agencies, principally agencies that conduct or support health care research, as well as Federal officials the Secretary may consider appropriate. 42 U.S.C. 299c(c)(3). Seven current members’ terms will expire in November 2024. To fill these positions, we are seeking individuals who: (1) are distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care; (2) are distinguished in the fields of health care quality research or health care improvement; (3) are distinguished in the practice of medicine; (4) are distinguished in other health professions; (5) represent the private health care sector (including health plans, providers, and purchasers) or are distinguished as administrators of health care delivery systems; (6) are distinguished in the fields of health care economics, information systems, law, ethics, business, or public policy; and (7) represent the interests of patients and consumers of health care, 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in these activities. AHRQ will accept nominations to serve on the Council in a representative capacity. The Council meets in the Washington, DC, metropolitan area, generally in Rockville, Maryland, approximately three times a year to provide broad guidance to the Secretary and AHRQ’s Director on the direction of and programs undertaken by AHRQ. Seven individuals will be selected by the Secretary to serve on the Council beginning with the meeting in the spring of 2024. Members generally serve 3-year terms. Appointments are staggered to permit an orderly rotation of membership. Interested persons may nominate one or more qualified persons for membership on the Council. Selfnominations are accepted. Nominations shall include: (1) a copy of the nominee’s resume or curriculum vitae; and (2) a statement that the nominee is willing to serve as a member of the Council. Selected candidates will be asked to provide detailed information concerning their financial interests, consultant positions and research grants and contracts, to permit evaluation of possible sources of conflict of interest. Please note that once a candidate is nominated, AHRQ may consider that nomination for future positions on the Council. VerDate Sep<11>2014 16:54 Feb 16, 2024 Jkt 262001 The Department seeks a broad geographic representation. In addition, AHRQ conducts and supports research concerning priority populations, which include: Inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care. See 42 U.S.C. 299(c). AHRQ also includes in its definition of priority populations those groups identified in section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. Nominations of persons with expertise in health care for these priority populations are encouraged. Dated: February 14, 2024. Marquita Cullom, Associate Director. [FR Doc. 2024–03401 Filed 2–16–24; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10110] Agency Information Collection Activities: Proposed Collection; Comment Request 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 April 22, 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: 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: Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. Contents 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 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–10110 Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals 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 AGENCY: SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: E:\FR\FM\20FEN1.SGM 20FEN1 Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 currently approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Use: Section 1847A of the Act requires that the Medicare Part B payment amounts for covered drugs and biologicals not paid on a cost or prospective payment basis be based upon manufacturers’ average sales price data submitted quarterly to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR part 414 subpart J. CMS, specifically, the Division of Data Analysis and Market-based Pricing (DDAMBP) will utilize the ASP data (ASP and number of units sold as specific in section 1847A of the Act) to determine the Medicare Part B drug payment amounts for CY 2005 and beyond. The manufacturers submit their ASP data for all of their National Drug Codes (NDC) for Part B drugs. DDAMBP compiles the data, analyzes the data and runs the data through software to calculate the volume-weighted ASP for all of the NDCs that are grouped within a given HCPCS code. The formula to calculate the volume-weighted ASP is the Sum (ASP * units) for all NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP payment amounts for several components within CMS that utilize 1847(A) payment methodologies to implement various payment policies including, but not limited to, ESRD, OPPS, OTP and payment models. CMS will also use reported ASP and units to calculate inflation adjusted coinsurance and rebates. The Department of Health and Human Services’ Office of the Inspector General also uses the ASP data in conducting studies. Form Number: CMS–10110 (OMB Control Number: 0938–0921); Frequency: Quarterly; Affected Public: Private and Business or other for-profits; Number of Respondents: 500; Number of Responses: 2,00; Total Annual Hours: VerDate Sep<11>2014 16:54 Feb 16, 2024 Jkt 262001 26,000. (For policy questions regarding this collection contact Felicia Brown at (410) 786–9287 or Felicia.brown@ cms.hhs.gov). William N. Parham, III, Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2024–03348 Filed 2–16–24; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10466] Agency Information Collection Activities: Submission for OMB Review; 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 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 March 21, 2024. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open DATES: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 12845 for Public Comments’’ or by using the search function. 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 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: Revision of a currently approved collection; Title of Information Collection: Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Use: The data collection and reporting requirements in ‘‘Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions’’ (78 FR 39494 (July 1, 2013)), address Federal requirements that states must meet with regard to the Exchange minimum function of performing eligibility determinations and issuing certificates of exemption from the shared responsibility payment. In the final regulation, CMS addresses standards related to eligibility, including the verification and eligibility determination process, eligibility redeterminations, options for states to rely on HHS to make eligibility determinations for certificates of exemption, and reporting. CMS developed four appendices of E:\FR\FM\20FEN1.SGM 20FEN1

Agencies

[Federal Register Volume 89, Number 34 (Tuesday, February 20, 2024)]
[Notices]
[Pages 12844-12845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110]


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 April 22, 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-10110 Manufacturer Submission of Average Sales Price (ASP) Data for 
Medicare Part B Drugs and Biologicals

    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

[[Page 12845]]

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 currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals; Use: Section 1847A of the Act requires that the 
Medicare Part B payment amounts for covered drugs and biologicals not 
paid on a cost or prospective payment basis be based upon 
manufacturers' average sales price data submitted quarterly to the 
Centers for Medicare & Medicaid Services (CMS). The reporting 
requirements are specified in 42 CFR part 414 subpart J.
    CMS, specifically, the Division of Data Analysis and Market-based 
Pricing (DDAMBP) will utilize the ASP data (ASP and number of units 
sold as specific in section 1847A of the Act) to determine the Medicare 
Part B drug payment amounts for CY 2005 and beyond. The manufacturers 
submit their ASP data for all of their National Drug Codes (NDC) for 
Part B drugs. DDAMBP compiles the data, analyzes the data and runs the 
data through software to calculate the volume-weighted ASP for all of 
the NDCs that are grouped within a given HCPCS code. The formula to 
calculate the volume-weighted ASP is the Sum (ASP * units) for all 
NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP 
payment amounts for several components within CMS that utilize 1847(A) 
payment methodologies to implement various payment policies including, 
but not limited to, ESRD, OPPS, OTP and payment models. CMS will also 
use reported ASP and units to calculate inflation adjusted coinsurance 
and rebates. The Department of Health and Human Services' Office of the 
Inspector General also uses the ASP data in conducting studies. Form 
Number: CMS-10110 (OMB Control Number: 0938-0921); Frequency: 
Quarterly; Affected Public: Private and Business or other for-profits; 
Number of Respondents: 500; Number of Responses: 2,00; Total Annual 
Hours: 26,000. (For policy questions regarding this collection contact 
Felicia Brown at (410) 786-9287 or [email protected]).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-03348 Filed 2-16-24; 8:45 am]
BILLING CODE 4120-01-P


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