Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63579 

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 

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/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: 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 

§ 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. 


ddrumheller on DSK120RN23PROD with NOTICES1
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. 

SUMMARY: 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. 

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 

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-2015- 

09-18/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 


ddrumheller on DSK120RN23PROD with NOTICES1