57958 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3499] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of 

Alternative Form of Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of alternative form of 

hearing. 

SUMMARY: The Food and Drug 

Administration (FDA) announces an 

alternative form of hearing regarding the 

Center for Drug Evaluation and 

Research’s (CDER’s) proposal to refuse 

to approve ITCA 650 (exenatide in 

DUROS device), a drug-device 

combination product that is the subject 

of a new drug application (NDA) 

submitted by Intarcia Therapeutics, Inc. 

(Intarcia). CDER is holding a public 

hearing before an advisory committee 

under FDA regulations as an alternative 

form of hearing. 

DATES: The meeting will be held 

virtually on September 21, 2023, from 9 

a.m. to 5:30 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 

including information regarding special 

accommodations due to a disability may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

LaToya Bonner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–2855, email: EMDAC@fda.hhs.gov; 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). 

SUPPLEMENTARY INFORMATION: 

Background: This advisory committee 

meeting is being held pursuant to a 

March 24, 2023, letter from the Chief 

Scientist of FDA, Dr. Namandje ́ N. 

Bumpus, wherein she granted Intarcia’s 

request under § 12.32(b)(3)(ii) (21 CFR 

12.32(b)(3)(ii)) for a public hearing 

before an advisory committee in lieu of 

a formal evidentiary public hearing 

under part 12 (21 CFR part 12). 

Intarcia submitted NDA 209053 for 

ITCA 650 (exenatide in DUROS device), 

a novel drug-device combination 

product on November 21, 2016, under 

section 505(b)(1) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 355(b)(1)). On September 21, 

2017, CDER issued a complete response 

(CR) letter to Intarcia under § 314.110(a) 

(21 CFR 314.110(a)) stating that NDA 

209053 could not be approved in its 

present form, describing the specific 

deficiencies and, where possible, 

recommending ways that Intarcia might 

remedy these deficiencies. On 

September 9, 2019, Intarcia resubmitted 

the NDA under section 505(b)(1) of the 

FD&C Act. On March 9, 2020, CDER 

issued a second CR letter stating that 

NDA 209053 could not be approved in 

its present form, describing the specific 

deficiencies and, where possible, 

recommending ways that Intarcia might 

remedy these deficiencies. The CR 

letters stated that Intarcia is required 

either to resubmit the application, fully 

addressing all deficiencies listed in the 

letter, or take other actions available 

under § 314.110 (i.e., resubmit the 

application, withdraw the application, 

or request an opportunity for a hearing). 

Applicable regulations, including 21 

CFR 10.75, also provide a mechanism 

for applicants to obtain formal review of 

one or more decisions reflected in a CR 

letter. 

On March 16, 2021, Intarcia 

submitted a request under 

§ 314.110(b)(3) for an opportunity for a 

hearing on whether there are grounds 

under section 505(d) of the FD&C Act 

for denying approval of NDA 209053. In 

the Federal Register of September 2, 

2021, FDA published a notice of 

opportunity for a hearing (NOOH) 

regarding CDER’s proposal to refuse to 

approve NDA 209053 submitted by 

Intarcia for ITCA 650 (86 FR 49334). 

The NOOH gave Intarcia an opportunity 

to request a hearing before the 

Commissioner of Food and Drugs on 

CDER’s proposal to refuse to approve 

NDA 209053. On September 13, 2021, 

Intarcia submitted a notice of 

participation and request for a hearing. 

Intarcia submitted data, information, 

and analyses in support of its hearing 

request on November 1, 2021, and 

February 15, 2022. 

On July 29, 2022, CDER issued, via 

email to Intarcia, a proposed order 

proposing to refuse to approve NDA 

209053 in its present form (see Docket 

No. FDA–2021–N–0874). Intarcia 

responded to CDER’s proposed order on 

October 10, 2022. 

On February 7, 2023, the Chief 

Scientist of FDA issued a letter to 

Intarcia and CDER that stated, in part: 

‘‘Under 21 CFR 12.32(a), a person 

seeking a hearing under 21 CFR part 12 

may request an alternative form of 

hearing, such as a hearing before a 

public advisory committee under 21 

CFR part 14.’’ Dr. Bumpus stated that 

she would grant a request from Intarcia 

for an alternative form of hearing under 

part 14 (21 CFR part 14) in lieu of a 

formal evidentiary hearing under part 

12. On February 20, 2023, Intarcia 

submitted a request in the form of a 

citizen petition under 21 CFR 10.30, 

requesting a public hearing before an 

advisory committee under part 14 in 

lieu of Intarcia’s pending request for a 

formal evidentiary hearing under part 

12. On March 24, 2023, Dr. Bumpus 

issued a letter granting Intarcia’s request 

for an alternative form of hearing. 

Accordingly, CDER is holding this 

meeting pursuant to the March 24, 2023, 

letter from Dr. Bumpus, wherein she 

granted Intarcia’s request under 

§ 12.32(b)(3)(ii) for a public hearing 

before an advisory committee in lieu of 

a formal evidentiary hearing. This 

document serves as the notice of an 

alternative form of hearing as required 

under § 12.32(e). 

Subject of Alternative Form of 

Hearing: CDER’s proposed order to 

refuse to approve ITCA 650 (exenatide 

in DUROS device) is the subject of the 

alternative form of hearing before the 

Endocrinologic and Metabolic Drugs 

Advisory Committee (see Docket No. 

FDA–2021–N–0874). 

Parties to the Alternative Form of 

Hearing: Intarcia Therapeutics, Inc. and 

the Center for Drug Evaluation and 

Research are the parties to the 

alternative form of hearing before the 

Endocrinologic and Metabolic Drugs 

Advisory Committee. 

Issues To Be Discussed: The issues 

presented at the hearing will be those 

related to the safety and efficacy of 

ITCA 650, a drug-device combination 

product that is the subject of an NDA 

submitted by Intarcia (NDA 209053), for 

the proposed indication, as an adjunct 

to diet and exercise, to improve 

glycemic control in adults with type 2 

diabetes mellitus. 

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 


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Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 57959 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: August 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18241 Filed 8–23–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–2436] 

Manufacturing Changes and 

Comparability for Human Cellular and 

Gene Therapy Products; Draft 

Guidance for Industry; Extension of 

the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

notice announcing the availability of a 

draft guidance entitled ‘‘Manufacturing 

Changes and Comparability for Human 

Cellular and Gene Therapy Products; 

Draft Guidance for Industry,’’ that 

appeared in the Federal Register of July 

14, 2023. We are taking this action in 

response to requests for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance published 

July 14, 2023 (88 FR 45222). Submit 

either electronic or written comments 

on the draft guidance by November 13, 

2023, to ensure that we consider your 

comment on the draft guidance before 

we begin work on the final version of 

the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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– 

2023–D–2436 for ‘‘Manufacturing 

Changes and Comparability for Human 

Cellular and Gene Therapy Products; 

Draft Guidance for Industry.’’ Received 

comments 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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: 

Karen Fikes, 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. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 14, 2023 (88 FR 

45222), we published a notice of 

availability for a draft guidance entitled 

‘‘Manufacturing Changes and 

Comparability for Human Cellular and 

Gene Therapy Products; Draft Guidance 

for Industry.’’ This action opened a 

docket with a 60-day comment period. 

We have received requests for a 30- 

day extension of the comment period for 

the draft guidance. We have considered 

the requests and are extending the 

comment period for the draft guidance 

for 60 days, until November 13, 2023. (A 

60-day extension would fall on 

November 11, 2023, which is a 

Saturday, so we have extended the 

comment period until the next business 

day, which is November 13, 2023.) We 

believe that a 60-day extension allows 

adequate time for interested persons to 

submit comments. 

Dated: August 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18235 Filed 8–23–23; 8:45 am] 

BILLING CODE 4164–01–P 


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