102914 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: March 31, 2021. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

SOHONOS (NDA 215559) was initially 

submitted on March 31, 2021. 

3. The date the application was 

approved: August 16, 2023. FDA has 

verified the applicant’s claim that NDA 

215559 was approved on August 16, 

2023. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 69 days 1,209 days 

or 1,773 days of patent term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29964 Filed 12–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0119] 

Fiscal Year 2025 Generic Drug Science 

and Research Initiatives Workshop; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the following public 

workshop entitled ‘‘FY 2025 Generic 

Drug Science and Research Initiatives 

Workshop.’’ The purpose of the public 

workshop is to provide an overview of 

the status of science and research 

initiatives for generic drugs and an 

opportunity for public input on these 

initiatives. FDA is seeking this input 

from a variety of interested parties— 

industry, academia, patient advocates, 

professional societies, and other 

interested parties—as it fulfills its 

commitment under the Generic Drug 

User Fee Amendments of 2022 (GDUFA 

III) to develop an annual list of science 

and research initiatives specific to 

generic drugs. FDA will take the 

information it obtains from the public 

workshop into account in developing its 

fiscal year (FY) 2026 Generic Drug User 

Fee Amendments (GDUFA) science and 

research initiatives. 

DATES: The public workshop will be 

held on June 3 and 4, 2025. Either 

electronic or written comments on this 

public workshop must be submitted by 

July 7, 2025. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public workshop will 

be held in person and will be accessible 

virtually. Registrants will have an 

opportunity to indicate their interest in 

attending the public workshop in 

person. If there are restrictions imposed 

by applicable health guidelines for inperson gatherings, or seating capacity 

limitations, registrants interested in 

attending the public workshop in 

person will be contacted. The public 

workshop will be held at the FDA White 

Oak Campus, 10903 New Hampshire 

Ave., Bldg. 31 Conference Center, the 

Great Room (Rm. 1503, sections B and 

C), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

Information, please refer to https://

www.fda.gov/about-fda/visitorinformation. 

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 July 7, 2025. 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–0119 for ‘‘FY 2025 Generic 

Drug Science and Research Initiatives 

Workshop; Public Workshop; Request 

for Comments.’’ Received comments, 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 102915 

1The GDUFA III commitment letter is available 

at https://www.fda.gov/media/153631/download. 

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: Sam 

Raney, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4732, Silver Spring, 

MD 20993, 240–402–7967, 

Sameersingh.Raney@fda.hhs.gov; or 

Robert Lionberger, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4722, 

Silver Spring, MD 20993, 240–402– 

7957, Robert.Lionberger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In July 2012, Congress passed the 

Generic Drug User Fee Amendments of 

2012 (GDUFA I) (Pub. L. 112–144). 

GDUFA I was designed to enhance 

public access to safe, high-quality 

generic drugs and to modernize the 

generic drug program. To support this 

goal, FDA agreed in the Generic Drug 

User Fee Act Program Performance 

Goals and Procedures (GDUFA I 

commitment letter) to work with 

industry and interested parties on 

identifying science and research 

initiatives specific to generic drugs for 

each fiscal year covered by GDUFA I. 

In August 2017, GDUFA was 

reauthorized until September 2022 

through the Generic Drug User Fee 

Amendments of 2017 (GDUFA II) 

(Public Law 115–52), and in September 

2022, GDUFA was reauthorized until 

September 2027 through GDUFA III 

(Pub. L. 117–180, 136 Stat. 2155). In the 

GDUFA Reauthorization Performance 

Goals and Program Enhancements Fiscal 

Years 2023–2027 (GDUFA III 

commitment letter),1 FDA agreed to 

conduct annual public workshops to 

solicit input from industry and 

interested parties for inclusion in an 

annual list of GDUFA III regulatory 

science initiatives. This public 

workshop scheduled for June 3 and 4, 

2025, seeks to fulfill this agreement. 

II. Topics for Discussion at the Public 

Workshop 

The purpose of this public workshop 

is to obtain input from industry and 

other interested parties on identifying 

generic drug science and research 

initiatives for FY 2026. FDA is 

interested in receiving input about 

regulatory science initiatives for the 

ongoing years of the GDUFA III science 

and research program, and particularly 

for FY 2026. 

Topics discussed during the 

workshop will focus on research that is 

needed to address scientific knowledge 

gaps and associated challenges 

impacting the development and 

regulatory assessment of generic 

products, including complex generics. 

As examples, topics discussed will 

likely focus on identifying what 

research is needed to clarify technical 

details related to implementing 

bioequivalence approaches 

recommended in FDA guidances for 

generic products with complex active 

ingredients and associated challenges 

(e.g., related to immunogenicity), or for 

those that are complex products (e.g., 

drug-device combination products), or 

for other generic products where 

research could address scientific 

uncertainties and, thereby, facilitate a 

more efficient approval pathway (e.g., a 

waiver of in vivo bioequivalence studies 

for solid oral dosage forms that 

currently do not have proper alternative 

methods to support such waivers). 

Additional topics that can enhance 

public access to high-quality, safe, and 

effective generic products may also be 

discussed. Specific presentations and 

discussions at this workshop will be 

announced at a later date and may differ 

from the topics above. Input about the 

topics above will help the Agency 

identify and expand its scientific focus 

for the next fiscal year. 

FDA will consider all comments made 

at this workshop or received through the 

docket (see ADDRESSES) as it develops its 

FY 2026 science and research 

initiatives. Information concerning the 

science and research initiatives for 

generic drugs can be found on the 

Science & Research website at https://

www.fda.gov/drugs/generic-drugs/ 

science-research. 

III. Participating in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online at https://

fda.zoomgov.com/webinar/register/WN_

wxxGXb5HSgKMAa2Q_sJLEw#/ 

registration. Registration may be 

performed at any time before or during 

the workshop. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact FDA 

via email at GDUFARegulatoryScience@

fda.hhs.gov no later than 11:59 p.m. 

Eastern Time on May 20, 2025. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present your 

public comments and which topic(s) 

you wish to address. Requests to 

provide public comments via a 

prerecorded presentation or a live 

presentation, including in-person or 

virtual presentations, should be 

submitted via email to 

GDUFARegulatoryScience@fda.hhs.gov 


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102916 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 

by 11:59 p.m. Eastern Time on April 3, 

2025. FDA will do its best to 

accommodate requests to make public 

comments that are within the scope of 

this public workshop; i.e., those that 

identify what research is needed to 

address specific challenges for generic 

product development or regulatory 

assessment. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the workshop. Based on the public 

comment presentation requests received 

by April 3, 2025, at 11:59 p.m. Eastern 

Time, FDA will determine the amount 

of time allotted to each presenter and 

the approximate time each oral 

presentation is to begin; FDA will select 

and notify participants by April 30, 

2025. If selected for presentation, any 

presentation materials must be emailed 

to GDUFARegulatoryScience@

fda.hhs.gov no later than May 20, 2025, 

11:59 p.m. Eastern Time. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. Please register online 

(as described above) to attend the 

workshop remotely (virtually). 

Registrants will receive a hyperlink that 

provides access to the webcast on both 

days. Although FDA verified the 

website addresses in this document, 

please note that websites are subject to 

change over time. 

Transcripts: Please be advised that as 

soon as a video recording and audio 

transcript of the public workshop are 

available, they will be accessible at 

https://www.regulations.gov or via the 

Science & Research FDA website 

accessible at https://www.fda.gov/drugs/ 

generic-drugs/science-research. They 

may also be available for viewing at the 

Dockets Management Staff (see 

ADDRESSES). 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29962 Filed 12–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–0681; FDA– 

2022–E–0682; FDA–2022–E–0683] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BYLVAY 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for BYLVAY and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by February 18, 2025. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 16, 2025. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 

February 18, 2025. 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 Nos. FDA– 

2022–E–0681, FDA–2022–E–0682, and 

FDA–2022–E–0683 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

BYLVAY.’’ 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 


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