Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77521 

Rm. 6200, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biological product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, SYMDEKO 

(tezacaftor/co-packaged with ivacaftor) 

indicated for the treatment of patients 

with cystic fibrosis aged 12 years and 

older who are homozygous for the 

F508del mutation or who have at least 

one mutation in the cystic fibrosis 

transmembrane conductance regulator 

gene that is responsive to tezacaftor/ 

ivacaftor based on in vitro data and/or 

clinical evidence. Subsequent to this 

approval, the USPTO received patent 

term restoration applications for 

SYMDEKO (U.S. Patent Nos. 7,645,789; 

7,776,905; 8,415,387; 8,598,181; 

8,623,905; and 9,035,072) from Vertex 

Pharmaceuticals Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

June 12, 2019, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of SYMDEKO 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

SYMDEKO is 2,832 days. Of this time, 

2,602 days occurred during the testing 

phase of the regulatory review period, 

while 230 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: May 15, 2010. 

The applicant claims May 14, 2010, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was May 15, 2010, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: June 28, 2017. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

SYMDEKO (NDA 210491) was initially 

submitted on June 28, 2017. 

3. The date the application was 

approved: February 12, 2018. FDA has 

verified the applicant’s claim that NDA 

210491 was approved on February 12, 

2018. 

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 616 days, 864 days, 

882 days, 1,001 days, 1,484 days, or 

1,532 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: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21677 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4085] 

Advancing Smoking Cessation: Food 

and Drug Administration and National 

Institutes of Health Priorities; Public 

Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Advancing Smoking 

Cessation: FDA and NIH Priorities.’’ 

Jointly convened by FDA and the 

National Institutes of Health (NIH), this 

public meeting will address the need for 

novel smoking cessation products to 

help individuals of all ages, including 

underserved and vulnerable 

populations, stop smoking. The overall 

goal of the meeting is to stimulate novel 

product development to reduce rates of 

smoking and related chronic illnesses. 

The meeting format will include 

presentations and panel discussions. 

DATES: The public meeting will be held 

in person with an option for virtual 

attendance on October 21, 2024, from 9 

a.m. to 4:30 p.m. Eastern Time. Submit 

requests to make oral presentations at 

the public meeting by 5 p.m. Eastern 

Time, October 1, 2024. Either electronic 

or written comments on this public 

meeting must be submitted by 

November 21, 2024. See the 


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77522 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held in the White Oak Great Room at the 

Food and Drug Administration, White 

Oak Campus, 10903 New Hampshire 

Ave., Silver Spring, MD 20993. Entrance 

for the public meeting participants (nonFDA 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/ 

visitor-information. 

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 November 21, 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 

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–4085 for ‘‘Advancing Smoking 

Cessation: FDA and NIH Priorities.’’ 

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 

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: 

Laura Chilaka, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 877– 

287–1373, TobaccoCessation@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This public meeting is intended to 

bring together key people in supporting 

research on and development of new 

smoking cessation products in order to 

stimulate novel product development to 

reduce the burden of smoking and 

related chronic illnesses. Participants 

will hear updates on NIH research and 

FDA operations. 

II. Topics for Discussion at the Public 

Meeting 

Session 1. NIH-supported smoking 

cessation research and areas of 

opportunity. This session will provide a 

brief overview of NIH areas of support 

and identification of gap areas including 

focus on underserved and vulnerable 

populations. 

Session 2. Update from FDA. This 

session will provide a brief overview of 

relevant FDA operations including focus 

on underserved and vulnerable 

populations. The session will discuss 

the regulatory framework for developing 

smoking cessation drugs, medical 

devices and their role in smoking 

cessation, and tobacco pathways. 

Session 3. Clinical and community 

perspectives. This session will offer a 

concise introduction to smoking 

cessation treatment considerations from 

the clinical viewpoint, with a special 

emphasis on underserved and diverse 

communities along with potential 

access and uptake challenges, through 

the lens of real-world experiences and 

diversity considerations. 

Session 4. Promising targets for 

development. This session will 

highlight selected new and emerging 

areas for intervention development 

including pharmacologic agents, brain 

stimulation, and digital therapeutics. In 

addition, we will discuss the potential 

endpoints for use in randomized trials 

of new interventions. 

Session 5. Regulatory paths forward. 

This session will discuss endpoints for 

smoking cessation drug development 

programs, evidence necessary to support 

their role in drug development, clinical 

outcome assessments, and innovative 

clinical trial designs and conduct, 

including trials integrated in clinical 

practice and clustering in trial design to 

increase participation from underserved 

communities. 

Session 6. Public comment. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77523 

related to cessation and should address 

the following questions: 

1. How can researchers increase 

enrollment for traditionally 

underrepresented populations in 

clinical trials (e.g., racial and ethnic 

minority populations, LGBTQ+ 

populations, rural populations)? 

2. Would there be interest in an 

externally led Patient Focused Drug 

Development (PFDD) meeting to better 

understand the challenges and barriers 

to smoking cessation from individuals 

trying to quit and what additional 

endpoints can be evaluated in smoking 

cessation clinical trials? 

3. What are some novel targets that 

could facilitate cigarette cessation 

product development? 

4. What challenges are researchers 

and/or drug developers facing in their 

efforts to identify novel targets for 

smoking cessation therapies? 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website to register: https://advancing

smokingcessation.eventbrite.com. 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. Persons interested in 

attending this public meeting in person 

must register by October 15, 2024, 11:59 

p.m. Eastern Time. Persons interested in 

attending this public meeting virtually 

must register by October 21, 2024, 9 

a.m. Eastern Time. 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. 

For special accommodations due to a 

disability, please visit the registration 

website: https://advancingsmoking

cessation.eventbrite.com. Please submit 

special accommodation requests no later 

than October 7, 2024. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during 

the public comment session. We will do 

our best to accommodate requests to 

make public comments. 

Oral presentations from the public 

will be scheduled between 

approximately 3:15 p.m. and 4:15 p.m. 

Eastern Time on October 21, 2024. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person (see FOR FURTHER

INFORMATION CONTACT) and submit a 

brief statement describing the general 

nature of the evidence or arguments 

they wish to present and the names and 

email addresses of proposed 

participants, on or before October 1, 

2024, by 5 p.m. Eastern Time. Topics 

should address the questions listed in 

II., Section 6. Individuals making formal 

oral presentations will not have the 

capacity to present slides during the 

public comment session. Individuals 

may submit presentation materials to 

the docket on or before November 21, 

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. 

Similarly, room for interested persons to 

participate in person may be limited. If 

the number of registrants requesting to 

speak in person during the open public 

hearing is greater than can be reasonably 

accommodated in the venue for the inperson portion of the meeting, FDA may 

conduct a lottery to determine the 

speakers who will be invited to 

participate in person. 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 focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin and 

will select and notify participants as 

soon as possible to provide speakers 

with adequate time to prepare. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. Please visit the following 

website for more information: https://

advancingsmokingcessation.

eventbrite.com. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). 

(Notice of this meeting is given 

pursuant to 21 CFR 10.65.) 

Dated: September 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21678 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–2396] 

Chemistry, Manufacturing, and 

Controls Development and Readiness 

Pilot Program; Program 

Announcement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing year three of the Chemistry, 

Manufacturing, and Controls (CMC) 

Development and Readiness Pilot 

(CDRP). This program facilitates the 

expedited CMC development of 

products under an investigational new 

drug application (IND) based on the 

anticipated clinical benefit of earlier 

patient access to the products. FDA has 

implemented this pilot program to assist 

with CMC readiness for products 

regulated by both the Center for 

Biologics Evaluation and Research 

(CBER) and the Center for Drug 

Evaluation and Research (CDER) that 

have accelerated clinical development 

timelines. To accelerate CMC 

development and facilitate CMC 

readiness, the pilot features increased 

communication between FDA and 

sponsors and explores the use of 

science- and risk-based regulatory 

approaches, as applicable. This notice 

outlines the eligibility criteria and 

process for submitting a request to 

participate in the pilot. 

DATES: Starting October 1, 2024, FDA 

will accept requests to participate in 

year three of the CDRP program. See the 

‘‘Participation’’ section of this document 

for eligibility criteria, instructions on 

how to submit a request to participate, 

and selection criteria and process. 

FOR FURTHER INFORMATION CONTACT: 

Tanya Clayton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4506, 

Silver Spring, MD 20993–0002, 301– 

796–0871; or James Myers, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

For general questions about the CDRP 

Program for CBER: industry.biologics@

fda.hhs.gov. 

For general questions about the CDRP 

Program for CDER: cder-opq-opro-cradinquiries@fda.hhs.gov. 


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