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. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80251 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Cellular, Tissue, and 

Gene Therapies Advisory Committee 

(the Committee). The general function of 

the Committee is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

November 21, 2024, from 10 a.m. to 4 

p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

The online web conference meeting 

will be available at the following link on 

the day of the meeting at https://

youtube.com/live/xztpe5-d9eY. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4489. 

The docket will close on November 20, 

2024. 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 November 20, 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. 

Comments received on or before 

November 14, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

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– 

2024–N–4489 for ‘‘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.’’ 

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.’’ FDA 

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 the 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: 

Cicely Reese or Marie DeGregorio, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 1232, Silver Spring, 

MD 20993–0002, 301–796–9025, email: 

CBERCTGTAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. On November 

21, 2024, the Committee will meet in 

open session to discuss and make 


lotter on DSK11XQN23PROD with NOTICES1
80252 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

recommendations on supplemental 

biologics license application 125586/ 

546 from AstraZeneca AB, submitted to 

confirm the clinical benefit of Andexxa 

(coagulation factor Xa (recombinant), 

inactivated -zhzo), for patients treated 

with rivaroxaban or apixaban when 

reversal of anticoagulation is needed 

due to life-threatening or uncontrolled 

bleeding. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

November 14, 2024, will be provided to 

the Committee. Oral presentations from 

the public will be scheduled between 

approximately 1:10 p.m. and 2:10 p.m. 

Eastern Time on November 21, 2024. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, along with the names, email 

addresses, and direct contact phone 

numbers of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before 12 p.m. Eastern Time on 

November 6, 2024. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by 6 p.m. Eastern Time 

on November 8, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Cicely Reese at 

CBERCTGTAC@fda.hhs.gov (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: September 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22561 Filed 10–1–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3653] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Promotion of 

Prescription Drugs Within a Talk Show 

Format 

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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with a proposed 

study entitled ‘‘Promotion of 

Prescription Drugs Within a Talk Show 

Format.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 2, 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 

December 2, 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 


lotter on DSK11XQN23PROD with NOTICES1