Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices 65689 

DATES: CDC will host three 

informational webinars. 

An informational webinar for State, 

Tribal, Local, and Territorial (STLT) 

officials only will be held: 

• Tuesday, October 3, 2023, 10:00– 

11:00 a.m. EDT. Please see the 

SUPPLEMENTARY INFORMATION section for 

pre-registration information. 

Informational Webinars for the 

general public will be held: 

• Thursday, October 12, 2023, 12:00– 

1:00 p.m. EDT. Please see the 

SUPPLEMENTARY INFORMATION section for 

pre-registration information. 

• Wednesday, October 18, 2023, 

3:00–4:00 p.m. EDT. Please see the 

SUPPLEMENTARY INFORMATION section for 

pre-registration information. 

Pre-registration is required for all 

webinars. Persons interested in 

participating in the webinars must preregister no later than one hour prior to 

the start of the webinar. 

FOR FURTHER INFORMATION CONTACT: 

Natalie Wendling or Dominic Cristiano, 

One Health Office, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE, Mailstop H16–5, Atlanta, 

Georgia 30329. Telephone: 404–639– 

8950. Email: onehealth@cdc.gov. 

SUPPLEMENTARY INFORMATION: CDC has 

partnered with the U.S. Department of 

the Interior (DOI), the U.S. Department 

of Agriculture (USDA), and other 

departments and agencies to develop a 

One Health framework to address 

zoonotic diseases and advance public 

health preparedness. On September 20, 

2023, CDC published a notice requesting 

public comment on the draft NOHFZoonoses (88 FR 64913). Public 

comments are due November 6, 2023 . 

The Framework can be found at Docket 

No. CDC–2023–0075 at 

www.regulations.gov. CDC, DOI, and 

USDA are offering informational 

webinars to present the Framework and 

answer questions. No public comment 

will be accepted at the webinars. 

Pre-Registration Information 

Persons interested in participating in 

the webinars must pre-register at the 

links below at least one hour prior to the 

start of the webinar. 

October 3, 2023 Webinar 

Interested STLT officials are invited 

to participate by registering with an 

official government email at the 

following zoom link: https://

cdc.zoomgov.com/webinar/register/WN_

xlBalA_aQPKetWfjpgNV6A. 

October 12, 2023 Webinar 

Interested persons or organizations 

are invited to participate by registering 

at the following zoom link: https://

cdc.zoomgov.com/webinar/register/WN_

cjNw5lJbRumLF1WkfwFF8A. 

October 18, 2023 Webinar 

Interested persons or organizations 

are invited to participate by registering 

at the following zoom link: https://

cdc.zoomgov.com/webinar/register/WN_

WObcRpTGQGKvC7ISzPCVPQ. 

Resources 

• Federal One Health Coordination: 

https://www.cdc.gov/onehealth/whatwe-do/federal-coordination.html. 

• United States Joint External 

Evaluation: https://www.who.int/ 

publications/i/item/WHO-WHE-CPI2017.13. 

• United States One Health Zoonotic 

Disease Prioritization Report: https://

www.cdc.gov/onehealth/pdfs/us-ohzdpreport-508.pdf. 

Dated: September 20, 2023. 

Tiffany Brown, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2023–20677 Filed 9–22–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–26, CMS–R– 

185, CMS–116, CMS–2746 and CMS–10261] 

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 25, 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: Clinical 

Laboratory Improvement Amendments 

(CLIA) Regulations; Use: The 

information is necessary to determine 

an entity’s compliance with the 

Congressionally-mandated program 

with respect to the regulation of 


ddrumheller on DSK120RN23PROD with NOTICES1
65690 Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices 

laboratory testing (CLIA). In addition, 

laboratories participating in the 

Medicare program must comply with 

CLIA requirements as required by 

section 6141 of OBRA 89. Medicaid, 

under the authority of section 

1902(a)(9)(C) of the Social Security Act, 

pays for services furnished only by 

laboratories that meet Medicare (CLIA) 

requirements. 

This is a revision of the information 

collection. Based on the notice of 

proposed rulemaking, published in the 

Federal Register on July 26, 2022 (87 FR 

44896), we are revising the information 

collection request by adding sections. 

The additional requirements include 

sections 493.1278, 493.1359, 493.1405– 

1411; 493.1423, 493.1443–1445, 

493.1461–1463; 493.1483; 493.1489– 

1491. These sections include 

histocompatibility (493.1278) and 

personnel (493.1359, 493.1405–1411; 

493.1423, 493.1443–1445, 493.1461– 

1463; 493.1483; 493.1489–1491) require 

laboratories to revise and update 

policies and procedures applicable to 

new or amended requirements. Form 

Number: CMS–R–26 (OMB Control 

Number: 0938–0612); Frequency: 

Monthly, occasionally; Affected Public: 

Business or other for-profits and Notfor-profit institutions, State, Local or 

Tribal Governments, and the Federal 

government; Number of Respondents: 

49,626; Total Annual Responses: 

88,259,802; Total Annual Hours: 

14,514,802. (For policy questions 

regarding this collection contact Jelani 

Sanaa at 410–786–1139). 

2. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Granting and Withdrawal of 

Deeming Authority to Private Nonprofit 

Accreditation Organizations and CLIA 

Exemption Under State Laboratory 

Programs; Use: The information 

required is necessary to determine 

whether a private accreditation 

organization/State licensure program 

standards and accreditation/licensure 

process is at least equal to or more 

stringent than those of the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). If an accreditation 

organization is approved, the 

laboratories that it accredits are 

‘‘deemed’’ to meet the CLIA 

requirements based on this 

accreditation. Similarly, if a State 

licensure program is determined to have 

requirements that are equal to or more 

stringent than those of CLIA, its 

laboratories are considered to be exempt 

from CLIA certification and 

requirements. The information collected 

will be used by HHS to: determine 

comparability/equivalency of the 

accreditation organization standards 

and policies or State licensure program 

standards and policies to those of the 

CLIA program; to ensure the continued 

comparability/equivalency of the 

standards; and to fulfill certain statutory 

reporting requirements. 

We are revising the information 

collection request by adding and 

amending collection requirements for 

493.553–557. The proposed rule 

published in the Federal Register on 

July 26, 2022 (87 FR 44896). These 

require laboratories to revise and update 

policies and procedures applicable to 

new or amended requirements. Form 

Number: CMS–R–185 (OMB control 

number: 0938–0686); Frequency: 

Occasionally; Affected Public: Private 

Sector—Business or other for-profits 

and Not-for-profit institutions; Number 

of Respondents: 9; Total Annual 

Responses: 9; Total Annual Hours: 

5,359. (For policy questions regarding 

this collection contact Arlene Lopez at 

410–786–6782.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Clinical 

Laboratory Improvement Amendments 

(CLIA) Application Form and 

Supporting Regulations; Use: Section 

353 (b) of the Public Health Service Act 

specifies that the laboratory must 

submit an application in such form and 

manner as the Secretary shall prescribe 

that describes the characteristics of the 

laboratory and examinations and 

procedures performed by the laboratory. 

The application must be completed by 

entities performing laboratory’s testing 

specimens for diagnostic or treatment 

purposes. This information is vital to 

the certification process. In this 

revision, the majority of changes were 

minor changes to the form and 

accompanying instructions to facilitate 

the completion and data entry of the 

form. We anticipate that the changes 

will not increase the time to complete 

the form. Form Number: CMS–116 

(OMB control number: 0938–0581); 

Frequency: Biennially and Occasionally; 

Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 64,598; Total Annual 

Responses: 64,598; Total Annual Hours: 

64,598. (For policy questions regarding 

this collection contact Kimberly Weaver 

at 410–786–3366.) 

4. Type of Information Collection 

Request: Reinstatement of a previously 

approved collection; Title of 

Information Collection: End Stage Renal 

Disease Death Notification; Use: The 

ESRD Death Notification form (CMS– 

2746) is completed by all Medicareapproved ESRD facilities upon death of 

an ESRD patient. Its primary purpose is 

to collect fact of death and cause of 

death of ESRD patients. The ESRD 

Program Management and Medical 

Information System (PMMIS) has the 

responsibility of collecting, maintaining, 

and disseminating, on a national basis, 

uniform data pertaining to ESRD 

patients and their treatment of care. All 

renal facilities approved to participate 

in the ESRD program are required by 

Public Law 95–292 to supply data to 

this system. 

Federal regulations require that the 

ESRD Networks examine the mortality 

rates of every Medicare-approved 

facility within its area of responsibility. 

CMS–2746 provides the necessary data 

to assist the ESRD Networks in making 

decisions that result in improved 

patient care and in cost-effective 

distribution of ESRD resources. The data 

is used by the ESRD Networks to verify 

facility deaths and to monitor facility 

performance. The form is also used by 

health care planning agencies and 

researchers to determine survival rates 

by diagnoses. This request is to revise 

the form to better align with the 

common verbiage used on standardized 

forms, by other Federal agencies, 

including the Census Bureau. Form 

Number: CMS–2746 (OMB control 

number: 0938–0448); Frequency: Yearly; 

Affected Public: Private Sector (Business 

or other for-profits, Not-for-Profit 

Institutions); Number of Respondents: 

7,726; Total Annual Responses: 

101,491; Total Annual Hours: 50,746. 

(For policy questions regarding this 

collection contact Christina Goatee at 

410–786–6689.) 

5. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Part C Medicare Advantage 

Reporting Requirements; Use: The 

Centers for Medicare and Medicaid 

Services (CMS) established reporting 

requirements for Medicare Advantage 

Organizations (MAOs) under the 

authority described in 42 CFR 

422.516(a). Each MAO must have an 

effective procedure to develop, compile, 

evaluate, and report to CMS, its 

enrollees, and the public at the times 

and in the manner that CMS requires. 

These Part C Reporting Requirements 

will provide key data to CMS on the 

utilization and cost of these benefits that 

has not been available since the removal 

of benefit utilization requirements in 

2011. This proposed collection will also 

build upon the previous collection-by 

asking for information regarding all 

unique supplemental benefits 

categories. These categories match the 

current Plan Benefit Package (PBP) 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices 65691 

which is submitted annually by plans. 

Additionally, the proposed collection 

will request information to be split out 

by the authority under which each plan 

offers the benefits (mandatory, optional, 

mandatory-SSBCI, mandatoryUniformity Flexibility). Form Number: 

CMS–10261 (OMB control number: 

0938–1054); Frequency: Annually; 

Affected Public: Business or other forprofits; Number of Respondents: 743; 

Total Annual Responses: 6,687; Total 

Annual Hours: 187,979. (For policy 

questions regarding this collection 

contact Lucia Patrone at (410) 786– 

8621). 

Dated: September 20, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–20739 Filed 9–22–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2079] 

Hospira, Inc., et al.; Withdrawal of 

Approval of Eight Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Hospira, Inc., et al.; 

Withdrawal of Approval of Eight 

Abbreviated New Drug Applications’’ 

that appeared in the Federal Register of 

June 2, 2023. The document announced 

the withdrawal of approval (as of July 3, 

2023) of eight abbreviated new drug 

applications (ANDAs) from multiple 

applicants. The document indicated that 

FDA was withdrawing approval of 

ANDA 077029, Calcipotriene Solution, 

0.005% after receiving a withdrawal 

request from Tolmar, Inc., 701 Centre 

Ave., Fort Collins, CO 80526. Before 

FDA withdrew the approval of this 

ANDA, Tolmar, Inc. informed FDA that 

it did not want the approval of the 

ANDA withdrawn. Because Tolmar, Inc. 

timely requested that approval of ANDA 

077029 not be withdrawn, the approval 

is still in effect. This document corrects 

that error. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Friday, June 2, 2023 

(88 FR 36320), in FR Doc. 2023–11744, 

the following correction is made: 

On page 36321, in the table, the entry 

for ANDA 077029 is removed. 

Dated: September 20, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20742 Filed 9–22–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0853] 

Yogurt Products Deviating From 

Standard of Identity; Amendment of 

Temporary Marketing Permit 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) are 

amending Chobani, LLC’s temporary 

permit to market test lower-fat yogurt 

products. The temporary permit is 

amended to allow the use of the test 

product as an ingredient in other 

nonstandardized food applications 

including drinkable beverages, dips, and 

sauces. This amendment will allow the 

applicant to continue to test market the 

test product, as ingredients, in whole or 

in part, in other nonstandardized foods 

and collect data on consumer 

acceptance of the test product. 

FOR FURTHER INFORMATION CONTACT: 

Marjan Morravej, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2371. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 28, 2023 (88 

FR 18322), we issued a notice 

announcing that we issued a temporary 

permit to Chobani, LLC, 200 Lafayette 

St., New York, NY 10012, to market test 

lower-fat yogurt products deviating from 

the general definition and standard of 

identity for yogurt with modified 

milkfat and fat-containing flavoring 

ingredients, and yogurt deviating from 

the yogurt standard of identity by using 

ultrafiltered nonfat milk as a basic dairy 

ingredient. The permit allowed for the 

test product to be manufactured at 3450 

Kimberly Rd. East, Twin Falls, ID 83301 

and 669 County Rd. 25, New Berlin, NY 

13411. 

We issued the permit to facilitate 

market testing of products that deviate 

from the requirements for the basic 

dairy ingredient provision of the yogurt 

standard of identity under 21 CFR 

131.200(b). 

Under our regulations at 21 CFR 

130.17(f), we are amending the 

temporary permit issued to Chobani, 

LLC, to allow the test product to be used 

as ingredients, in whole or in part, in 

other nonstandardized foods. All other 

conditions and terms of this permit 

remain the same. 

Dated: September 20, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20736 Filed 9–22–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Heart, Lung, 

and Blood Institute Initial Review 

Group, Mentored Patient-Oriented 

Research Study Section, October 26, 

2023, 10:00 a.m. to October 27, 2023, 6 

p.m., National Institutes of Health, 

Rockledge 1, 6705 Rockledge Drive, 

Bethesda, MD 20892, which was 

published in the Federal Register on 

September 14, 2023, FR Doc 2023– 

19907, 88 FRN 63115. 

The National Heart, Lung, and Blood 

Institute Initial Review Group, 

Mentored Patient-Oriented Research 

Study Section meeting is being 

amended due to a change of the meeting 

time formats. The meeting will be held 

on October 26, 2023, from 9:00 a.m. to 

October 27, 6:00 p.m. This meeting will 

be a video assisted meeting, and closed 

to the public. 

Dated: September 18, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–20648 Filed 9–22–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 


ddrumheller on DSK120RN23PROD with NOTICES1