Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 83133 

utilized for a fresh transfer, the date of 

cryopreservation is not currently 

collected. In recent years, frozen-embryo 

transfers have become more prevalent as 

they may improve pregnancy success 

rates in certain groups of ART patients. 

For frozen-embryo transfers, the date at 

which fresh embryos were 

cryopreserved (with the date of oocyte 

retrieval) can be used to determine the 

stage of the embryo at the time of 

cryopreservation, which is an important 

predictor of ART success. Therefore, 

CDC proposes to add the date of freshembryo cryopreservation to the 

currently collected information as it will 

allow classification of embryo stage for 

frozen-embryo transfers and improve 

the reporting of factors that impact ART 

success rates. Addition: Date fresh 

embryos were cryopreserved—this date 

is to be reported for all frozen-embryo 

transfers. 

Proposed Modifications to Data 

Validation Procedures 

Pursuant to the previous FRN notice 

(86 FR 20496), CDC proposed to 

conduct targeted validation of ART 

clinics to better capture systematic 

reporting errors by assessing certain 

reporting characteristics that may 

predict erroneously inflated ART 

success rates. In addition, CDC 

proposed to remove a clinic’s reported 

success rates from the annual ART 

reports if major data discrepancies were 

identified. Identifying major data 

discrepancies would require the review 

of a larger number of clinic records at 

select clinics, thereby increasing data 

collection burden for clinics. Given the 

additional burden, CDC will not pursue 

implementation of targeted validation of 

ART clinics and identification of major 

discrepancies during data validation. 

CDC will continue to calculate 

discrepancy rates for key variables and 

provide feedback to clinics to improve 

the reporting of data used to report 

success rates as described in the FRN 

notice (80 FR 51811). In addition, CDC 

will continue removing a clinic’s 

reported success rates from annual ART 

reports if the clinic was selected for 

annual ART data validation but 

declined to participate as described in 

the FRN notice (86 FR 20496). 

Tiffany Brown, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2023–26137 Filed 11–27–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–102 and CMS– 

105] 

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 

January 29, 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 http://

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/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–102 and CMS–105—CLIA Budget 

Workload Reports and Supporting 

Regulations in 42 CFR 493.1–.2001 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: CLIA Budget 

Workload Reports and Supporting 

Regulations in 42 CFR 493.1–.2001; Use: 

The Clinical Laboratory Improvement 

Amendments of 1988 (CLIA), Public 

Law 100–578 were enacted on October 

31, 1988. Provisions of this law 

mandated by Congress require entities 

(with few exceptions) that test human 

specimens be subject to Federal 

regulation and have in effect a 

certificate issued by the Department of 

Health and Human Services. CLIA 

mandates that fees must be paid by each 

laboratory to obtain or renew a 

certificate and for the cost of 


lotter on DSK11XQN23PROD with NOTICES1
83134 Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 

compliance determination if applicable. 

The certificate issuance fees will be set 

by CMS at levels sufficient to recover 

the full costs of administering the 

operational provisions of CLIA, 

including approval and monitoring of 

proficiency testing programs and 

accrediting bodies and implementing 

Federal requirements. Fees will also be 

collected by CMS to cover the costs of 

inspecting non-accredited laboratories 

and validating accrediting laboratories 

based on the lab’s volume and scope of 

testing. Currently, CMS contracts with 

50 State agencies to conduct surveys of 

all participating health care facilities. As 

part of their contract, CMS reimburses 

the State agencies for the reasonable 

cost of conducting surveys. This 

information collection gathers the 

information necessary to reimburse 

State agencies for a reasonable cost. 

Form Number: CMS–102 and CMS–105 

(OMB control number: 0938–0599); 

Frequency: Yearly/Quarterly; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

50; Total Annual Responses: 50; Total 

Annual Hours: 34. (For policy questions 

regarding this collection contact Eric 

Powell at 312–886–0791). 

Dated: November 22, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–26201 Filed 11–27–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4597] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Shortages Data 

Collections 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

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 of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collections associated with Shortages 

Data Collections and with notifications 

to FDA of an interruption or permanent 

discontinuance in manufacturing of 

certain medical devices as required by 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

January 29, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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 

must include the Docket No. FDA– 

2023–N–4597 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Shortages 

Data Collections.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 


lotter on DSK11XQN23PROD with NOTICES1