Agency Information Collection Activities: Submission for OMB Review; Comment Request, 63579-63580 [2023-20041]

Download as PDF Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices notes. The NAC members will then receive an update from the AHRQ Director. The agenda will also include an update on the Subcommittee of the National Advisory Council (SNAC) for AHRQ’s Patient-Centered Outcomes Research Trust Fund (PCORTF) Investments, as well as an update on the Subcommittee of the National Advisory Council (SNAC) for the National Action Alliance to Advance Patient Safety. The meeting will also include a discussion about the Consumer Assessment of Healthcare Providers and System (CAHPS). The meeting is open to the public and will adjourn at 4 p.m. For information regarding how to access the meeting as well as other meeting details, including information on how to make a public comment, please go to https:// www.ahrq.gov/news/events/nac/. The final agenda will be available on the AHRQ website no later than Thursday, November 2, 2023. Dated: September 12, 2023. Marquita Cullom, Associate Director. [FR Doc. 2023–20068 Filed 9–14–23; 8:45 am] BILLING CODE 4160–90–P [Document Identifier: CMS–10638 and CMS– 1500] 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 ddrumheller on DSK120RN23PROD with NOTICES1 17:05 Sep 14, 2023 Jkt 259001 William Parham at (410) 786–4669. 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: Add-On Payments for New Medical Services and Technologies Paid Under the Inpatient Prospective Payment System (IPPS); Use: Sections 1886(d) (5) (K) and (L) of the Act establish a process of identifying SUPPLEMENTARY INFORMATION: Centers for Medicare & Medicaid Services VerDate Sep<11>2014 Comments on the collection(s) of information must be received by the OMB desk officer by October 16, 2023. 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 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. DATES: FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES SUMMARY: 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. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 63579 and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as ‘‘new technologies’’) under the Inpatient Prospective Payment System (IPPS). Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered new if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or technology may be considered for NTAP if, ‘‘based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate.’’ In order to qualify for NTAP under the traditional pathway, a specific technology must be ‘‘new’’ and demonstrate that they are not substantially similar to existing technologies under the requirements of § 412.87(b)(2) of our regulations. The statutory provision contemplated the special payment treatment for new technologies until such time as data are available to reflect the cost of the technology in the DRG weights through recalibration (no less than 2 years and no more than 3 years). Alternative pathway technologies must also be ‘‘new’’ but are considered not substantially similar to existing technologies. Responses to the questions in the application help CMS determine if and how the applicant meets the established. Form Number: CMS–10638 (OMB Control Number: 0938–1347); Frequency: Yearly; Affected Public: Private Sector, Business or other forprofits and Not-for-profits institutions; Number of Respondents: 62; Number of Responses: 62; Total Annual Hours: 1,655. (For policy questions regarding this collection contact Sophia Chan at 410–786–8348.) 2. Type of Information Collection Request: Extension of a currently approved collection of information; Title of Information Collection: Health Insurance Common Claims Form; Use: The CMS–1500 and the CMS–1490S forms are used to deliver information to CMS in order for CMS to reimburse for provided services. Medicare Administrative Contractors use the data collected on the CMS–1500 and the CMS–1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS–1500 is submitted by physicians/ suppliers for all Part B Medicare. E:\FR\FM\15SEN1.SGM 15SEN1 63580 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices Serving as a common claim form, the CMS–1500 can be used by other thirdparty payers (commercial and nonprofit health insurers) and other Federal programs (e.g., TRICARE, RRB, and Medicaid). Form Number: CMS–1500 (OMB Control Number: 0938–1197); Frequency: Occasionally; Affected Public: Private Sector, Business or other for-profit and not-for-profit institutions; Number of Respondents: 2,451,781; Number of Responses: 975,664,249; Total Annual Hours: 17,163,310. (For policy questions regarding this collection contact Charlene Parks at 410–786–8684.) Dated: September 12, 2023. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2023–20041 Filed 9–14–23; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3771] Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.’’ Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format. These forms are expected to result in improved accuracy and timeliness of FDA’s identification and review of those submissions containing information on PMRs and PMCs. This guidance covers the purpose of each form, when to use these forms, and how to submit these forms. The guidance also explains where applicants will be able to find the forms and instructions. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:05 Sep 14, 2023 Jkt 259001 This guidance finalizes the draft guidance of the same name issued on October 21, 2020. DATES: The announcement of the guidance is published in the Federal Register on September 15, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment 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 comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • 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 written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received should include the Docket No. FDA– 2018–N–3771 for ‘‘Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments 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 comments. 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. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ 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 to read background documents or the electronic and written/paper comments received, 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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63579-63580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20041]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10638 and CMS-1500]


Agency Information Collection Activities: Submission for OMB 
Review; 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 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.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by October 16, 2023.

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 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/PRA-Listing.

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: Add-On Payments 
for New Medical Services and Technologies Paid Under the Inpatient 
Prospective Payment System (IPPS); Use: Sections 1886(d) (5) (K) and 
(L) of the Act establish a process of identifying and ensuring adequate 
payment for new medical services and technologies (sometimes 
collectively referred to in this section as ``new technologies'') under 
the Inpatient Prospective Payment System (IPPS). Section 
1886(d)(5)(K)(vi) of the Act specifies that a medical service or 
technology will be considered new if it meets criteria established by 
the Secretary after notice and opportunity for public comment. Section 
1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or 
technology may be considered for NTAP if, ``based on the estimated 
costs incurred with respect to discharges involving such service or 
technology, the DRG prospective payment rate otherwise applicable to 
such discharges under this subsection is inadequate.''
    In order to qualify for NTAP under the traditional pathway, a 
specific technology must be ``new'' and demonstrate that they are not 
substantially similar to existing technologies under the requirements 
of Sec.  412.87(b)(2) of our regulations. The statutory provision 
contemplated the special payment treatment for new technologies until 
such time as data are available to reflect the cost of the technology 
in the DRG weights through recalibration (no less than 2 years and no 
more than 3 years). Alternative pathway technologies must also be 
``new'' but are considered not substantially similar to existing 
technologies. Responses to the questions in the application help CMS 
determine if and how the applicant meets the established. Form Number: 
CMS-10638 (OMB Control Number: 0938-1347); Frequency: Yearly; Affected 
Public: Private Sector, Business or other for-profits and Not-for-
profits institutions; Number of Respondents: 62; Number of Responses: 
62; Total Annual Hours: 1,655. (For policy questions regarding this 
collection contact Sophia Chan at 410-786-8348.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection of information; Title of Information Collection: 
Health Insurance Common Claims Form; Use: The CMS-1500 and the CMS-
1490S forms are used to deliver information to CMS in order for CMS to 
reimburse for provided services. Medicare Administrative Contractors 
use the data collected on the CMS-1500 and the CMS-1490S to determine 
the proper amount of reimbursement for Part B medical and other health 
services (as listed in section 1861(s) of the Social Security Act) 
provided by physicians and suppliers to beneficiaries. The CMS-1500 is 
submitted by physicians/suppliers for all Part B Medicare.

[[Page 63580]]

Serving as a common claim form, the CMS-1500 can be used by other 
third-party payers (commercial and nonprofit health insurers) and other 
Federal programs (e.g., TRICARE, RRB, and Medicaid). Form Number: CMS-
1500 (OMB Control Number: 0938-1197); Frequency: Occasionally; Affected 
Public: Private Sector, Business or other for-profit and not-for-profit 
institutions; Number of Respondents: 2,451,781; Number of Responses: 
975,664,249; Total Annual Hours: 17,163,310. (For policy questions 
regarding this collection contact Charlene Parks at 410-786-8684.)

    Dated: September 12, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-20041 Filed 9-14-23; 8:45 am]
BILLING CODE 4120-01-P

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