Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80249 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name Total burden 

hours 

Average hourly 

wage rate * 

Total cost 

burden 

4. Data File(s) Submission ...................................................................................................... 85 64.58 5,489 

Total .................................................................................................................................. 308 NA 19,891 

* Mean hourly wage rate of $64.58 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2023 National 

Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at https://www.bls.gov/oes/current/naics4_621100.htm. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 26, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–22578 Filed 10–1–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10844 and CMS– 

10157] 

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 November 1, 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: Revision of a currently 

approved collection; Title of 

Information Collection: Small Biotech 

Exception and Biosimilar Delay 

Information Collection Request (ICR) for 

Initial Price Applicability Year 2027; 

Use: Under the authority in sections 

11001 and 11002 of the Inflation 

Reduction Act of 2022 (Pub. L. 117– 

169), the Centers for Medicare & 

Medicaid Services (CMS) is 

implementing the Medicare Drug Price 

Negotiation Program, codified in 

sections 1191 through 1198 of the Social 

Security Act (the Act). The Information 

Collection Request Forms for the Small 

Biotech Exception and Biosimilar Delay 

Information Collection Request for 

Initial Price Applicability Year 2027 

must be submitted to CMS before CMS 

establishes the selected drug list for 

initial price applicability year 2027. 

Small Biotech Exception: In 

accordance with section 1192(d)(2) of 

the Act, the term ‘‘negotiation-eligible 

drug’’ excludes, with respect to the 

initial price applicability years 2026, 

2027, and 2028, a qualifying single 

source drug that meets the requirements 

for the exception for small biotech drugs 

(the ‘‘Small Biotech Exception,’’ or 

‘‘SBE’’). 


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80250 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

This information is required in order 

for CMS to accurately identify whether 

a given drug meets the criteria for the 

Small Biotech Exception in accordance 

with section 1192(d)(2) of the Act. To 

ensure that only covered Part D drugs 

that meet the requirements for the SBE 

are excluded from the term 

‘‘negotiation-eligible drug,’’ a 

manufacturer that seeks the SBE for its 

covered Part D drug (‘‘Submitting 

Manufacturer’’) must submit 

information to CMS about the company 

and its products in order for the drug to 

be considered for the exception. If the 

Submitting Manufacturer seeks the SBE 

for a covered Part D drug it acquired 

after December 31, 2021, the Submitting 

Manufacturer must also submit 

information related to the separate 

entity that had the Medicare Coverage 

Gap Discount Program agreement for the 

drug on December 31, 2021. If the 

Submitting Manufacturer was acquired 

by another entity after December 31, 

2021, the Submitting Manufacturer must 

provide information regarding that 

acquiring entity for CMS to assess 

whether the acquisition triggers the 

limitation at section 1192(d)(2)(B)(ii) of 

the Act. 

Biosimilar Delay: In accordance with 

section 1192(f)(1)(B) of the Act, the 

manufacturer of a biosimilar biological 

product (‘‘Biosimilar Manufacturer’’ of a 

‘‘Biosimilar’’) may submit a request, 

prior to the selected drug publication 

date, for CMS’ consideration to delay 

the inclusion of a negotiation-eligible 

drug that includes the reference product 

for the Biosimilar (such a negotiationeligible drug is herein referred to as a 

‘‘Reference Drug’’) on the selected drug 

list for a given initial price applicability 

year (the ‘‘Biosimilar Delay’’). This 

information is required in order for CMS 

to accurately determine if a drug meets 

the criteria for the Biosimilar Delay for 

initial price applicability year 2027 in 

accordance with section 1192(f) of the 

Act. To ensure that the delay of 

selection and negotiation of biologics is 

only applied if there is a high likelihood 

of biosimilar market entry that meets the 

requirements for the Biosimilar Delay, a 

Biosimilar Manufacturer that seeks the 

Biosimilar Delay must submit 

information to CMS related to the 

Biosimilar. This information includes 

identifying information for the 

Biosimilar and the Reference Drug; the 

licensure status of the Biosimilar; 

attestations that the Biosimilar 

Manufacturer is not the same or treated 

as the same entity as the Reference 

Manufacturer, that the Biosimilar 

Manufacturer and the Reference 

Manufacturer (who is the manufacturer 

of the Reference Drug) have not entered 

into an agreement that requires or 

incentivizes the Biosimilar 

Manufacturer to submit the Biosimilar 

Delay, or directly or indirectly restricts 

the quantity of the Biosimilar that may 

be sold in the United States over a 

specified period of time; and 

documentation specified under section 

1192(f)(3) of the Act to demonstrate 

there is a high likelihood of Biosimilar 

market entry within two years of the 

statutorily-defined selected drug 

publication date for initial price 

applicability year 2027. Form Number: 

CMS–10844 (OMB control number: 

0938–1443); Frequency: Once; Affected 

Public: Private sector, Business or other 

for-profit; Number of Respondents: 25; 

Total Annual Responses: 25; Total 

Annual Hours: 415; (For policy 

questions regarding this collection 

contact Elisabeth Daniel at 667–290– 

8793.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: The HIPAA 

Eligibility Transaction System (HETS); 

Use: CMS created the HIPAA (Health 

Insurance Portability and 

Accountability Act of 1996) Eligibility 

Transaction System (HETS) to provide 

HIPAA Accredited Standards 

Committee X12 270/271 health care 

eligibility inquiries (270) and responses 

(271) on a real-time basis. HETS allows 

health care providers or their designees 

to check Medicare beneficiary eligibility 

data in real-time. They use HETS to 

prepare accurate Medicare claims, 

determine beneficiary liability, or check 

eligibility for specific services. HETS 

allows users to submit HIPAA 

compliant 270 eligibility request over a 

secure connection and receive 271 

responses in real-time. In creating the 

HETS system, federal law requires that 

CMS take precautions to minimize the 

security risk to federal information 

systems. Accordingly, CMS requires that 

trading partners who wish to connect to 

the HETS 270/271 system via the CMS 

Extranet and/or internet to agree to the 

HETS Rules of Behavior and the HETS 

Authorized Representative Roles and 

Responsibilities terms as a condition of 

receiving Medicare eligibility 

information. Applicants complete the 

entire Trading Partner Agreement form 

to indicate agreement with CMS trading 

partner terms and provide sufficient 

information to establish connectivity to 

the service and assure that those entities 

that access the Medicare eligibility 

information are aware of applicable 

provisions and penalties for the misuse 

of information. 

CMS uses the Trading Partner 

Agreement Form to capture certain 

information whereby a person certifies 

that they are fully aware of all penalties 

related to the use of PHI and their access 

to this data from the HETS application. 

The information is an attestation by the 

authorized representative of an entity 

that wishes to access the Medicare 

eligibility information to conduct realtime eligibility transactions. The 

authorized representative is a person 

responsible for business decisions on 

behalf of the Organization who is 

submitting the access request. The data 

captured includes the authorized 

representative’s name, title contact 

number and the name of the submitting 

entity. Other data captured is the 

submitter’s National Provider Identifier, 

business name, billing address, physical 

address, and telephone number. 

The Trading Partner Agreement Form 

is also used by CMS to capture certain 

information whereby a person identifies 

the particular connectivity protocol that 

they will use to connect to CMS and 

specific organization information which 

is reviewed and authorized prior to the 

access being granted. Form Number: 

CMS–10157 (OMB control number: 

0938–0960); Frequency: Yearly; Affected 

Public: Private Sector, State, Local, or 

Tribal Governments, Federal 

Government, Business or other forprofits, Not-for-profits institutions; 

Number of Respondents: 1,000; Total 

Annual Responses: 1,000; Total Annual 

Hours: 250. (For policy questions 

regarding this collection contact 

William Money at 410–786–1956). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–22547 Filed 10–1–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4489] 

Cellular, Tissue, and Gene Therapies 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments— 

Supplemental Biologics License 

Application 125586/546 From 

AstraZeneca AB for Andexxa 

(Coagulation Factor Xa (Recombinant), 

Inactivated -zhzo); November 21, 2024 

AGENCY: Food and Drug Administration, 

HHS. 


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