Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Guidance for Industry; Availability, 52058-52060 [2024-13690]
Download as PDF
52058
Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
TABLE—ANDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Drug
Applicant
ANDA 040118 ......................
ANDA 040291 ......................
Carisoprodol, Aspirin and Codeine Phosphate Tablets,
325 milligrams (mg), 200 mg, and 16 mg.
Fluorouracil Injection, 50 mg/milliliters (mL) ...................
ANDA 071849 ......................
Morphine Sulfate Injectable, 0.5 mg/mL .........................
ANDA 074133 ......................
ANDA 076648 ......................
Metoprolol Tartrate Injectable, 1 mg/mL .........................
Nitrofurantoin (Monohydrate/Macrocrystals) Capsules,
75 mg, and 25 mg.
Ondansetron Hydrochloride (HCl) Preservative Free Injection, Equivalent to (EQ) 2 mg base/mL.
Ondansetron HCl Injectable, EQ 2 mg base/mL ............
Ondansetron HCl Injection, EQ 2 mg base/mL ..............
Dexamethasone Sodium Phosphate Injection, EQ 4 mg
phosphate/mL.
Mepivacaine HCl and Levonordefrin Injection, 0.05 mg/
mL; 2%.
Sandoz Inc., 100 College Rd. West, Princeton, NJ
08540.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Hospira, Inc., 275 North Field Dr., Building H1–3S,
Lake Forest, IL 60045.
Do.
Aurobindo Pharma USA Inc., 279 Princeton-Hightstown
Rd., East Windsor, NJ 08520.
American Regent, Inc., 5 Ramsey Rd., Shirley, NY
11967.
Do.
Do.
Do.
ANDA 077387 ......................
ANDA 077582 ......................
ANDA 079039 ......................
ANDA 087440 ......................
ANDA 088388 ......................
ANDA 090578 ......................
Ampicillin and Sulbactam For Injection, EQ 10 grams(g)
base/vial and EQ 5 grams (g) base/vial.
ANDA 090579 ......................
Ampicillin and Sulbactam For Injection, EQ 1 g base/
vial, EQ 500 mg base/vial, EQ 2 g base/vial, and EQ
1 g base/vial.
Duloxetine HCl Capsules, Delayed-Release Pellets, EQ
20 mg base, EQ 30 mg base, and EQ 60 mg base.
ANDA 090723 ......................
ANDA 207266 ......................
Bupivacaine HCl Injectable, 0.75% .................................
ANDA 207794 ......................
Busulfan Injection, 6 mg/mL ...........................................
ANDA 209068 ......................
Chlorthalidone Tablets, 25 mg and 50 mg .....................
ANDA 212223 ......................
Captopril Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg
ANDA 212287 ......................
Piperacillin and Tazobactam For Injection, EQ 2 g
base/vial, EQ 250 mg base/vial, EQ 3 g base/vial,
EQ 375 mg base/vial, EQ 4 g base/vial, and EQ 500
mg base/vial.
Cefepime HCl For Injection, EQ 1 g base/vial and EQ 2
g base/vial.
Succinylcholine Chloride Injection, 20 mg/mL ................
ANDA 212721 ......................
ddrumheller on DSK120RN23PROD with NOTICES1
ANDA 213552 ......................
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of July 22, 2024.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from table 1. Introduction or delivery for
introduction into interstate commerce of
products listed in table 1 without an
approved new drug application or
ANDA violates sections 505(a) and
301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a) and
331(d)). Drug products that are listed in
table 1 that are in inventory on July 22,
2024 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
ICON Clinical Research, LLC, U.S. Agent for Deproco,
Inc., 4130 ParkLake Ave., Suite 400, Raleigh, NC
27612.
EAS Consulting Group, LLC, U.S. Agent for Astral
SteriTech Pvt. Ltd., 1700 Diagonal Rd., #750, Alexandria, VA 22314.
Do.
Marksans Pharma, Inc., U.S. Agent for Marksans
Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor,
Rm. 430, Hauppauge, NY 11788.
Baxter Healthcare Corp., One Baxter Pkwy., Deerfield,
IL 60015.
Nexus Pharmaceuticals, Inc., 400 Knightsbridge Pkwy.,
Lincolnshire, IL 60069.
Elity LLC, U.S. Agent for Sunny Pharmtech Inc., 175
SW 166th Ave., Pembroke Pines, FL 33027.
Pharmobedient Consulting, LLC, U.S. Agent for Seton
Pharmaceuticals, LLC, 642 North East 3rd Ave., Fort
Lauderdale, FL 33304.
EAS Consulting Group, LLC.
Do.
Nexus Pharmaceuticals, Inc.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13660 Filed 6–20–24; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2023–D–1275]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Demonstrating Bioequivalence for
Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s)
Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to
No Systemic Bioavailability, and Are
Locally Acting; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry (GFI) #279
entitled ‘‘Demonstrating Bioequivalence
SUMMARY:
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\21JNN1.SGM
21JNN1
Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
for Type A Medicated Articles
Containing Active Pharmaceutical
Ingredient(s) Considered to be Poorly
Soluble in Aqueous Media, That Exhibit
Little to No Systemic Bioavailability,
and Are Locally Acting.’’ This final
guidance describes an approach to
satisfy the requirements for the
completion of the Bioequivalence
technical section for generic Type A
medicated articles (TAMAs) containing
poorly soluble, locally acting, active
pharmaceutical ingredients (APIs) that
have little to no systemic absorption,
and for which blood level studies are
not considered appropriate to
demonstrate product bioequivalence.
The suggested approach described in
this guidance uses a combination of in
vitro and in vivo data to support a
determination of bioequivalence to
address the unique challenges
associated with demonstrating
bioequivalence of TAMAs containing
poorly soluble, locally acting APIs that
have little to no systemic absorption.
The announcement of the
guidance is published in the Federal
Register on June 21, 2024.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
ddrumheller on DSK120RN23PROD with NOTICES1
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’’).
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
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–1275 for ‘‘Demonstrating
Bioequivalence for Type A Medicated
Articles Containing Active
Pharmaceutical Ingredient(s)
Considered to be Poorly Soluble in
Aqueous Media, That Exhibit Little to
No Systemic Bioavailability, and Are
Locally Acting.’’ 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.’’ 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-201509-18/pdf/2015-23389.pdf.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
52059
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Ian
Hendricks, Center for Veterinary
Medicine (HFV–172), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0853,
Ian.Hendricks@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
In the Federal Register of June 8, 2023
(88 FR 37551), FDA published the
notice of availability for a draft guidance
entitled ‘‘Demonstrating Bioequivalence
for Type A Medicated Articles
Containing Active Pharmaceutical
Ingredient(s) Considered to be Poorly
Soluble in Aqueous Media, That Exhibit
Little to No Systemic Bioavailability,
and Are Locally Acting,’’ giving
interested persons until August 7, 2023,
to comment on the draft guidance. In
response to a request for an extension,
we extended the comment period for the
draft guidance to October 16, 2023
(August 16, 2023, 88 FR 55702).
FDA received two comment
submissions on the draft guidance and
those comments were considered as the
guidance was finalized. For example,
we revised the final guidance to clearly
state that it does not cover APIs that are
systemically absorbed because they are
already addressed in other guidances. In
addition, several editorial changes were
made to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated June 8, 2023.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Demonstrating
Bioequivalence for Type A Medicated
E:\FR\FM\21JNN1.SGM
21JNN1
52060
Federal Register / Vol. 89, No. 120 / Friday, June 21, 2024 / Notices
Articles Containing Active
Pharmaceutical Ingredient(s)
Considered to be Poorly Soluble in
Aqueous Media, That Exhibit Little to
No Systemic Bioavailability, and Are
Locally Acting.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in section 512(n)(1) of the
Federal Food Drug and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved
under OMB control number 0910–0669.
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13690 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–N–4066; FDA–
2023–N–0918; FDA–2023–N–4259; FDA–
2023–N–4849; and FDA–2021–N–0471]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
FDA Recall Regulations ..........................................................................................................................................
Food Labeling Regulations ......................................................................................................................................
Export Certificates for FDA Regulated Products .....................................................................................................
Food Allergen Labeling and Reporting ....................................................................................................................
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption—Agricultural Water ............................................................................................................................................................
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13638 Filed 6–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2017–D–0154]
Considerations in Demonstrating
Interchangeability With a Reference
Product: Update; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
17:46 Jun 20, 2024
Jkt 262001
guidance for industry entitled
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product: Update.’’ This draft guidance
describes considerations regarding a
switching study or studies intended to
support a demonstration that a proposed
therapeutic protein product is
interchangeable with a reference
product for the purposes of submitting
a marketing application or supplement
under the Public Health Service Act
(PHS Act). After considering any
comments received in the docket for
this draft guidance, we intend to revise
the final guidance for industry entitled
‘‘Considerations in Demonstrating
Interchangeability With a Reference
Product’’ issued on May 14, 2019, to
amend sections in that document
regarding the subject addressed in this
draft guidance.
Submit either electronic or
written comments on the draft guidance
DATES:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0249
0910–0381
0910–0498
0910–0792
6/30/2027
5/31/2027
6/30/2027
6/30/2027
0910–0816
6/30/2027
by August 20, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins 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
E:\FR\FM\21JNN1.SGM
21JNN1
Agencies
[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52058-52060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13690]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1275]
Demonstrating Bioequivalence for Type A Medicated Articles
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly
Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry (GFI) #279 entitled
``Demonstrating Bioequivalence
[[Page 52059]]
for Type A Medicated Articles Containing Active Pharmaceutical
Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That
Exhibit Little to No Systemic Bioavailability, and Are Locally
Acting.'' This final guidance describes an approach to satisfy the
requirements for the completion of the Bioequivalence technical section
for generic Type A medicated articles (TAMAs) containing poorly
soluble, locally acting, active pharmaceutical ingredients (APIs) that
have little to no systemic absorption, and for which blood level
studies are not considered appropriate to demonstrate product
bioequivalence. The suggested approach described in this guidance uses
a combination of in vitro and in vivo data to support a determination
of bioequivalence to address the unique challenges associated with
demonstrating bioequivalence of TAMAs containing poorly soluble,
locally acting APIs that have little to no systemic absorption.
DATES: The announcement of the guidance is published in the Federal
Register on June 21, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-1275 for ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered to
be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' 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.'' 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Ian Hendricks, Center for Veterinary
Medicine (HFV-172), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0853, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 8, 2023 (88 FR 37551), FDA
published the notice of availability for a draft guidance entitled
``Demonstrating Bioequivalence for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and
Are Locally Acting,'' giving interested persons until August 7, 2023,
to comment on the draft guidance. In response to a request for an
extension, we extended the comment period for the draft guidance to
October 16, 2023 (August 16, 2023, 88 FR 55702).
FDA received two comment submissions on the draft guidance and
those comments were considered as the guidance was finalized. For
example, we revised the final guidance to clearly state that it does
not cover APIs that are systemically absorbed because they are already
addressed in other guidances. In addition, several editorial changes
were made to improve clarity. The guidance announced in this notice
finalizes the draft guidance dated June 8, 2023.
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Demonstrating Bioequivalence for Type
A Medicated
[[Page 52060]]
Articles Containing Active Pharmaceutical Ingredient(s) Considered to
be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in section 512(n)(1) of the Federal Food Drug and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13690 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P