13720 Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 

and online catalog disclosures) +5,806 

hours (online label posting)]. 

Estimated annual labor cost burden: 

$24,690,012 in labor costs [which is 

derived from $22,255,572 (testing) + 

$50,195 (reporting) + $15,309 

(recordkeeping) + $2,129,800 (labeling) 

+ $128,996 (online and catalog 

disclosures) + $110,140 (online label 

posting)]. 

Estimated annual non-labor cost 

burden: $3,000,000. 

Request for Comment 

On December 5, 2023, the FTC sought 

public comment on the information 

collection requirements associated with 

the Rule. 88 FR 84330. One comment 

only stated, ‘‘Good,’’ but added nothing 

further. No other germane comments 

were received. Pursuant to the OMB 

regulations, 5 CFR part 1320, that 

implement the PRA, 44 U.S.C. 3501 et 

seq., the FTC is providing this second 

opportunity for public comment while 

seeking OMB approval to renew the preexisting clearance for the Rule. 

Your comment—including your name 

and your state—will be placed on the 

public record of this proceeding. 

Because your comment will be made 

public, you are solely responsible for 

making sure that your comment does 

not include any sensitive personal 

information, such as anyone’s Social 

Security number; date of birth; driver’s 

license number or other state 

identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure that your 

comment does not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Josephine Liu, 

Assistant General Counsel for Legal Counsel. 

[FR Doc. 2024–03726 Filed 2–22–24; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–102 and 105] 

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 March 25, 2024. 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: CLIA Budget 

Workload Reports; 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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices 13721 

(OMB control number: 0938–0599); 

Frequency: Yearly, quarterly, and semiannually; 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.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–03675 Filed 2–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10164 A/B] 

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 

April 23, 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–10164 A/B Medicare Electronic 

Data Interchange (EDI) Registration and 

Electronic Data Interchange Enrollment 

Form 

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: Medicare 

Electronic Data Interchange (EDI) 

Registration and Electronic Data 

Interchange Enrollment Form; Use: The 

purpose of this collection is to obtain 

information that will be subsequently 

used during transaction exchange for 

identification of Medicare providers/ 

suppliers and authorization of requested 

electronic data interchange (EDI) 

functions. The EDI Registration Form 

and the Medicare Enrollment Forms are 

completed by Medicare providers/ 

suppliers and submitted to CMS 

Medicare Administrative Contractors 

(MACs). Authorization is needed for 

providers/suppliers to send/receive 

Health Insurance Portability and 

Accountability Act (HIPAA) standard 

transactions directly (or through a 

designated 3rd party) to/from Medicare 

contractors. Medicare contractors will 

use the information for initial set-up 

and maintenance of the access 

privileges. CMS has allowed each MAC 

to create their own organization specific 

forms given they are comparable in 

terms of content of forms 10164A and 

10164B, to transmit data files 

electronically between themselves and 

their trading partners. The Standards for 

Electronic Transactions final rule, 45 

CFR part 162 subpart K § 162.1101 

through subpart R § 162.1802, 

(hereinafter referred to as ‘‘Transactions 

Rule’’) published August 17, 2000, 

adopted standards for health care 

transactions and code sets. Subsequent 

to the Transactions Rule, CMS–0003–P 

and CMS–0005–P proposed 

modifications to the adopted standards 

essential to permit initial 

implementation of the standards 

throughout the entire healthcare 

industry. Currently, MACs have a 

process in place to enroll providers for 

electronic billing and other EDI 

transactions. In support of the HIPAA 

Transactions Rule, the purpose of this 

Paperwork Reduction Act (PRA) request 

is to establish a prescribed amount of 

data that must be submitted by 

providers/suppliers that is sufficient to 

address all HIPAA transactions. Form 

Number: CMS–10164 A/B (OMB control 

number: 0938–0983); Frequency: Once; 

Affected Public: Private and Business or 

other for-profits; Number of 

Respondents: 1,181,209; Number of 

Responses: 1,181,209; Total Annual 

Hours: 393,706. (For policy questions 

regarding this collection contact 


ddrumheller on DSK120RN23PROD with NOTICES1