Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 83131 

payment protections until the 

contractor’s obligation is fulfilled. The 

contracting officer uses the information 

on the SF 28 to determine the 

acceptability of individuals proposed as 

sureties. 

C. Annual Burden 

Respondents: 14,259. 

Total Annual Responses: 14,269. 

Total Burden Hours: 14,255. 

D. Public Comment 

A 60-day notice was published in the 

Federal Register at 88 FR 64433, on 

September 19, 2023. No comments were 

received. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division, by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0001, Certain Federal 

Acquisition Regulation Part 28 

Requirements. 

William Clark, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2023–26176 Filed 11–27–23; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

[OMB Control No. 9000–0037; Docket No. 

2023–0053; Sequence No. 9] 

Submission for OMB Review; 

Presolicitation Notice and Response 

AGENCY: Department of Defense (DOD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Notice. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act, the 

Regulatory Secretariat Division has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve a revision of a previously 

approved information collection 

requirement regarding presolicitation 

notice and response. 

DATES: Submit comments on or before 

December 28, 2023. 

ADDRESSES: Written comments and 

recommendations for this 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 

Review—Open for Public Comments’’ or 

by using the search function. 

FOR FURTHER INFORMATION CONTACT: 

Zenaida Delgado, Procurement Analyst, 

at telephone 202–969–7207, or 

zenaida.delgado@gsa.gov. 

SUPPLEMENTARY INFORMATION: 

A. OMB Control Number, Title, and 

Any Associated Form(s) 

9000–0037, Presolicitation Notice and 

Response. 

B. Need and Uses 

This clearance covers the information 

that offerors must submit to comply 

with the following Federal Acquisition 

Regulation (FAR) requirements: 

• FAR 14.205. For sealed bidding, 

presolicitation notices briefly describe 

requirements and provide other 

essential information to enable potential 

bidders to determine whether they have 

an interest in the invitation and if 

appropriate, respond by communicating 

their interest in receiving the invitation 

for bid. 

• FAR 15.201(c). For contracting by 

negotiation, presolicitation notices 

provide a means of early exchanges of 

information about future acquisitions 

between Government and industry, to 

which potential offerors may respond 

with feedback concerning acquisition 

strategy, terms and conditions, and any 

other concerns or questions. 

• FAR 36.213–2. For construction 

contracts, presolicitation notices are 

required for construction requirements 

in excess of the simplified acquisition 

threshold to communicate essential 

information on the requirements, to 

which potential bidders may respond by 

communicating their interest in 

receiving the invitation for bid. 

Presolicitation notices are used by the 

Government to inform, and, where 

specified, solicit a response from 

potential offerors or bidders. The 

primary purposes of the notices are to 

improve small business access to 

acquisition information and enhance 

competition by identifying contracting 

and subcontracting opportunities. 

The contracting officer will use the 

information as follows: 

• For sealed bidding, to include 

interested bidders in the distribution of 

the invitations for bids; and 

• For contracting by negotiation, to 

consider the industry feedback in 

shaping the acquisition strategy. 

C. Annual Burden 

Respondents: 143,218. 

Total Annual Responses: 429,654. 

Total Burden Hours: 34,372. 

D. Public Comment 

A 60-day notice was published in the 

Federal Register at 88 FR 64434, on 

September 19, 2023. No comments were 

received. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division, by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0037, Presolicitation 

Notice and Response. 

William Clark, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2023–26177 Filed 11–27–23; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2023–0093] 

Reporting of Pregnancy Success Rates 

From Assisted Reproductive 

Technology (ART) Programs; 

Proposed Modifications to Data 

Collection Fields and Data Validation 

Procedures; Request for Comment 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) in the 

Department of Health and Human 

Services (HHS) announces the opening 

of a docket to obtain comment on and 

review of proposed modifications to 

data collection fields for reporting of 

pregnancy success rates from assisted 

reproductive technology (ART) 

programs and proposed modifications to 

data validation procedures. This 

reporting is required by the Fertility 

Clinic Success Rate and Certification 

Act of 1992 (FCSRCA). 

DATES: Written comments must be 

received on or before January 29, 2024. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2023– 

0093 by either of the methods listed 

below. 

Do not submit comments by email. 

CDC does not accept comments by 

email. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 


lotter on DSK11XQN23PROD with NOTICES1
83132 Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 

• Mail: Division of Reproductive 

Health, National Center for Chronic 

Disease Prevention and Health 

Promotion, Centers for Disease Control 

and Prevention, 4770 Buford Highway 

NE, Mailstop S107–2, Atlanta, Georgia 

30341; Attention: Assisted Reproductive 

Technology Surveillance and Research 

Team. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Mithi Sunderam, Division of 

Reproductive Health, National Center 

for Chronic Disease Prevention and 

Health Promotion, Centers for Disease 

Control and Prevention, 4770 Buford 

Highway NE, Mailstop S107–2, Atlanta, 

Georgia 30341; Telephone: 1–800–232– 

4636; Email: ARTinfo@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. In addition, CDC invites comments 

specifically on the following 

modifications to (1) data collection 

fields for reporting of pregnancy success 

rates from assisted reproductive 

technology (ART) programs; and (2) data 

validation procedures regarding the 

following proposals in this document: 

• CDC proposal to remove the 

requirement for clinics to report dosage 

information for fertility medications 

including Clomiphene, Letrozole, and 

long-acting FSH. 

• CDC proposal to remove the 

requirement for clinics to report 

information on research cycle study 

type. 

• CDC proposal to add the 

requirement for clinics to report date of 

cryopreservation for fresh embryos. 

• CDC proposal not to pursue targeted 

validation of clinics and identification 

of major data discrepancies. 

Please note that comments received, 

including attachments and other 

supporting materials, are part of the 

public record and are subject to public 

disclosure. Comments will be posted on 

https://www.regulations.gov. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. If 

you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be on 

public display. CDC will review all 

submissions and may choose to redact, 

or withhold, submissions containing 

private or proprietary information such 

as Social Security numbers, medical 

information, inappropriate language, or 

duplicate/near duplicate examples of a 

mass-mail campaign. Do not submit 

comments by email. CDC does not 

accept comments by email. 

Background 

On August 26, 2015, HHS/CDC 

published a notice in the Federal 

Register (80 FR 51811) announcing the 

overall reporting requirements of the 

National ART Surveillance System. This 

notice described who shall report to 

HHS/CDC the process for reporting by 

each ART program; the data to be 

reported; the process for external 

validation of clinic data; and the 

contents of the published reports. CDC 

has obtained approval from the Office of 

Management and Budget under the 

Paperwork Reduction Act to collect this 

information which is needed to 

determine the annual pregnancy success 

rates for each clinic that provides ART 

services. This data collection is 

approved under OMB Control Number 

0920–0556, expiration date: December 

31, 2024. CDC subsequently published a 

notice in the Federal Register on 

clarifications and modifications on 

December 15, 2016 (81 FR 90854), and 

a notice on clarifications and 

corrections on November 5, 2019 (84 FR 

59625). In 2021, CDC published a notice 

in the Federal Register (86 FR 20496) on 

changes to data validation of ART 

clinics. Subsequently, CDC published a 

notice in the Federal Register on June 

10, 2022 (87 FR 35555) that added data 

collection fields and modified reporting 

requirements. The purpose of the 

subject notice is to (1) update data 

collection fields to reflect changes in 

ART practice that may impact 

pregnancy success rates; and (2) update 

the ART data validation process. This 

notice provides opportunity for public 

review and comment for the proposed 

modifications to data collection fields 

and data validation procedures. 

Proposed Modifications to Data 

Collection Fields 

CDC is currently collecting 

information on Clomiphene dosage, 

Letrozole dosage, and other oral 

medication dosage (80 FR 51811; 

Section III ‘‘What to Report’’: F 

‘‘Stimulation and Retrieval’’). 

Clomiphene and Letrozole are 

established treatment options for 

ovulation induction and may be 

administered based on patient 

diagnostics to increase the chances of 

ovulation and pregnancy. Other oral 

medications such as insulin-sensitizing 

agents may be used in specific groups of 

patients. Therefore, it is important to 

monitor the type of medication used, 

and CDC will continue to collect 

information on whether Clomiphene, 

Letrozole or other oral medication were 

used. However, dosage regimens for 

these medications follow established 

guidelines and are less likely to show 

variability in how they are 

administered. Given these treatment 

protocols, collection of these data can be 

streamlined. In addition, CDC is 

currently collecting dosage information 

on long-acting follicle stimulating 

hormone (FSH) medication. Since this 

medication is no longer used in ART 

practice, CDC proposes discontinuing 

the collection of information on this 

medication. Therefore, CDC proposes to 

remove the requirement for ART clinics 

to report associated dosage information 

related to (1) Clomiphene, Letrozole, or 

other oral medication; and (2) longacting FSH. Deletion: Clomiphene 

dosage (Total mgs), Letrozole dosage 

(Total mgs), other oral medication 

dosage, long-acting FSH (Total mgs). 

CDC is currently collecting 

information on the type of research 

cycle performed by ART clinics (80 FR 

51811; Section III ‘‘What to Report’’: G 

‘‘Laboratory Information’’). Only a small 

number of research cycles are reported 

to CDC each year (i.e., 10 cycles in 

reporting year 2019, 7 cycles in 

reporting year 2020, and 0 cycles in 

reporting year 2021). CDC will continue 

to collect information on whether a 

cycle can be classified as a research 

cycle. CDC proposes to remove the 

requirement for clinics to report the 

research cycle study type, as only a 

small number of research cycles are 

performed each year. Deletion: Research 

cycle study type—if the cycle was a 

research cycle. This deletion will apply 

to all data fields for research study 

types: Device study, Protocol study, 

Pharmaceutical study, Laboratory 

technique, Other research. 

CDC is currently collecting 

information on fresh and frozen-embryo 

transfer procedures (80 FR 51811; 

Section III ‘‘What to Report’’: H 

‘‘Transfer Information’’). Embryo stage 

at the time of transfer is an important 

predictor of pregnancy success rates. 

For fresh-embryo transfer procedures, 

embryo stage can be determined by 

calculating the difference between the 

date of transfer and the date of oocyte 

retrieval. Both dates are currently 

collected. However, if fresh embryos 

were cryopreserved instead of being 


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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