Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing, 57958-57959 [2023-18241]
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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.
Notice of alternative form of
hearing.
ACTION:
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),
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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17:08 Aug 23, 2023
Jkt 259001
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
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.
Notice of availability; extension
of comment period.
ACTION:
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:
SUMMARY:
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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,
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17:08 Aug 23, 2023
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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
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57959
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-201509-18/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.
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 30day 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.
SUPPLEMENTARY INFORMATION:
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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]]>Agencies
[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57958-57959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18241]
[[Page 57958]]
-----------------------------------------------------------------------
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: [email protected]; 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.
Namandj[eacute] N. Bumpus, wherein she granted Intarcia's request under
Sec. 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 Sec. 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 Sec. 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 Sec.
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 Sec. 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 Sec.
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
[[Page 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
