Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Guidance for Industry; Availability, 27633-27635 [2021-10756]
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Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
27633
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR part; activity
Total
annual
disclosures
Average
burden per
disclosure
Total hours
§§ 101.3 and 101.22; statement of identity labeling
requirements.
§ 101.4; ingredient labeling requirements ...................
§ 101.5; requirement to specify the name and place
of business of the manufacturer, packer, or distributor.
§ 101.9; labeling requirements for disclosure of nutrition information.
§ 101.7; declaration of net quantity of contents ..........
Section 403(w)(1) of the FD&C Act; declaration of
food allergens.
Guidance document entitled ‘‘Labeling of Certain
Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration’’.
12
2
24
0.5 (30 minutes) .....
12
12
12
2
2
24
24
1 .............................
0.25 (15 minutes) ...
24
6
12
2
24
4 .............................
96
12
12
2
2
24
24
0.5 (30 minutes) .....
1 .............................
12
24
12
1
12
1 .............................
12
Total ......................................................................
........................
........................
........................
................................
186
1 There
jbell on DSKJLSW7X2PROD with NOTICES
Number of
disclosures
per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. Our
estimate of the number of respondents
is based on the number of regulatory
submissions to TTB for beers that do not
meet the definition of a ‘‘malt beverage’’
under the FAA Act. Based on its records
of submissions received from
manufacturers of such products, TTB
estimates the annual number of
respondents to be 12 and the annual
number of disclosures to be 24.
Our estimates of the average burden
per disclosure for each collection
provision are based on our experience
with food labeling under the Agency’s
jurisdiction. The estimated average
burden per disclosure for §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.7
are equal to, and based upon, the
estimated average burden per disclosure
approved by OMB in OMB control
number 0910–0381. We further estimate
that the labeling burden of section
403(w)(1) of the FD&C Act, which
specifies requirements for the
declaration of food allergens, will be 1
hour based upon the similarity of the
requirements to that of § 101.4. Finally,
we estimate that a respondent will
spend 1 hour reading the guidance.
The guidance also refers to previously
approved collections of information
found in our regulations. The
collections of information in §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.7
have been approved under OMB control
number 0910–0381. Allergen labeling of
these beers under section 403(w)(1) of
the FD&C Act, which was added by the
Food Allergen Labeling and Consumer
Protection Act of 2004, has been
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
approved under OMB control number
0910–0792.
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10750 Filed 5–20–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3764]
Demonstrating Bioequivalence for
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles Containing Active
Pharmaceutical Ingredients
Considered To Be Soluble in Aqueous
Media; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a final
guidance for industry (GFI) #171
entitled ‘‘Demonstrating Bioequivalence
for Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles Containing Active
Pharmaceutical Ingredients Considered
To Be Soluble in Aqueous Media.’’ This
guidance describes how the Agency
intends to evaluate requests for waiving
the requirement for performing in vivo
bioequivalence studies for animal drugs
administered orally as soluble powders
or as Type A medicated articles
SUMMARY:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
manufactured from active
pharmaceutical ingredients considered
to be soluble in aqueous media.
The announcement of the
guidance is published in the Federal
Register on May 21, 2021.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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’’).
E:\FR\FM\21MYN1.SGM
21MYN1
27634
Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–
2019–D–3764 for ‘‘Demonstrating
Bioequivalence for Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles Containing Active
Pharmaceutical Ingredients Considered
To Be Soluble in Aqueous Media.’’
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.
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
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.
FOR FURTHER INFORMATION CONTACT:
• Biopharmaceutics and
Pharmacokinetics: Marilyn Martinez,
Center for Veterinary Medicine (HFV–
100), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855,
240–402–0635, Marilyn.Martinez@
fda.hhs.gov.
• Manufacturing Chemistry:
Catherine Finnegan, Center for
Veterinary Medicine (HFV–147), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–402–
0650, Catherine.Finnegan@fda.hhs.gov.
• Generic Drug Approval
Requirements/Solubility Concerns: Ian
S. 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:
I. Background
In the Federal Register of September
30, 2019 (84 FR 51595), FDA published
the notice of availability for a draft
guidance entitled ‘‘Demonstrating
Bioequivalence for Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles Containing Active
Pharmaceutical Ingredients Considered
to be Soluble in Aqueous Media’’ giving
interested persons until November 29,
2019, to comment on the draft guidance.
This guidance describes how the
Agency intends to evaluate requests for
waiving the requirement for performing
in vivo bioequivalence studies
(biowaivers) for animal drugs
administered orally as soluble powders
or as Type A medicated articles
manufactured from active
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
pharmaceutical ingredients (APIs)
considered to be soluble in aqueous
media (water-soluble APIs). This
guidance expands upon GFI #35,
‘‘Bioequivalence Guidance,’’ published
November 8, 2006, to include
biowaivers for soluble powder oral
dosage form products as well as Type A
medicated articles manufactured from
APIs considered to be soluble in
aqueous media. This guidance offers
particular focus on criteria for the
waiver of the requirements for
submitting in vivo bioequivalence study
data.
This guidance is applicable to generic
investigational new animal drug
(JINAD) files and to abbreviated new
animal drug applications (ANADAs).
Although the recommendations in this
guidance refer to generic drug
applications, the general principles
described may also be applicable to new
animal drug applications (NADAs),
investigational new animal drug (INAD)
files, and supplemental NADAs. This
guidance does not address Type A
medicated articles manufactured from
APIs considered to be insoluble in
aqueous media.
FDA received no comments on the
draft guidance. The Agency made a
minor change to the title of the guidance
and other minor editorial changes to
improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated September 30,
2019.
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 Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles Containing Active
Pharmaceutical Ingredients Considered
To Be Soluble in Aqueous Media.’’ 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. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in section 512(n)(1) of the
Federal Food, Drug, and Cosmetic Act
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
(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 either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidance-industry
or https://www.regulations.gov.
Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10756 Filed 5–20–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0458]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Vaccines and Related Biological
Products Advisory Committee (the
Committee). The general function of the
Committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on June
10, 2021, from 8:30 a.m. to 3:40 p.m. ET.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform. The
online web conference meeting will be
available at the following link on the
day of the meeting: https://youtu.be/
70Xhn3K9SlQ.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0458.
The docket will close on June 9, 2021.
Submit either electronic or written
comments on this public meeting by
June 9, 2021. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 9, 2021.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 9, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before June
3, 2021, will be provided to the
committee. Comments received after
June 3, 2021, and by June 9, 2021, will
be taken into consideration by FDA. In
the event that the meeting is cancelled,
FDA will continue to evaluate any
relevant applications, submissions, or
information, and consider any
comments submitted to the docket, as
appropriate.
You may submit comments 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
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
27635
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–0458 for ‘‘Vaccines and Related
Biological Products; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ 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.’’ FDA
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 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 the 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:
Prabhakara Atreya or Kathleen Hayes,
Center for Biologics Evaluation and
Research, Food and Drug
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Notices]
[Pages 27633-27635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10756]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3764]
Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles Containing Active Pharmaceutical
Ingredients Considered To Be Soluble in Aqueous Media; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a final guidance for industry (GFI) #171
entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage
Form Products and Type A Medicated Articles Containing Active
Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media.''
This guidance describes how the Agency intends to evaluate requests for
waiving the requirement for performing in vivo bioequivalence studies
for animal drugs administered orally as soluble powders or as Type A
medicated articles manufactured from active pharmaceutical ingredients
considered to be soluble in aqueous media.
DATES: The announcement of the guidance is published in the Federal
Register on May 21, 2021.
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'').
[[Page 27634]]
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-2019-D-3764 for ``Demonstrating Bioequivalence for Soluble Powder
Oral Dosage Form Products and Type A Medicated Articles Containing
Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous
Media.'' 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:
Biopharmaceutics and Pharmacokinetics: Marilyn Martinez,
Center for Veterinary Medicine (HFV-100), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 240-402-0635,
[email protected].
Manufacturing Chemistry: Catherine Finnegan, Center for
Veterinary Medicine (HFV-147), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0650,
[email protected].
Generic Drug Approval Requirements/Solubility Concerns:
Ian S. 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 September 30, 2019 (84 FR 51595), FDA
published the notice of availability for a draft guidance entitled
``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles Containing Active Pharmaceutical
Ingredients Considered to be Soluble in Aqueous Media'' giving
interested persons until November 29, 2019, to comment on the draft
guidance. This guidance describes how the Agency intends to evaluate
requests for waiving the requirement for performing in vivo
bioequivalence studies (biowaivers) for animal drugs administered
orally as soluble powders or as Type A medicated articles manufactured
from active pharmaceutical ingredients (APIs) considered to be soluble
in aqueous media (water-soluble APIs). This guidance expands upon GFI
#35, ``Bioequivalence Guidance,'' published November 8, 2006, to
include biowaivers for soluble powder oral dosage form products as well
as Type A medicated articles manufactured from APIs considered to be
soluble in aqueous media. This guidance offers particular focus on
criteria for the waiver of the requirements for submitting in vivo
bioequivalence study data.
This guidance is applicable to generic investigational new animal
drug (JINAD) files and to abbreviated new animal drug applications
(ANADAs). Although the recommendations in this guidance refer to
generic drug applications, the general principles described may also be
applicable to new animal drug applications (NADAs), investigational new
animal drug (INAD) files, and supplemental NADAs. This guidance does
not address Type A medicated articles manufactured from APIs considered
to be insoluble in aqueous media.
FDA received no comments on the draft guidance. The Agency made a
minor change to the title of the guidance and other minor editorial
changes to improve clarity. The guidance announced in this notice
finalizes the draft guidance dated September 30, 2019.
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
Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
Containing Active Pharmaceutical Ingredients Considered To Be Soluble
in Aqueous Media.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in section 512(n)(1) of the Federal Food, Drug, and
Cosmetic Act
[[Page 27635]]
(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
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.
Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10756 Filed 5-20-21; 8:45 am]
BILLING CODE 4164-01-P
