Biomarkers and Surrogate Endpoints in Clinical Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability, 55619-55620 [2021-21688]
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
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 FDA’s guidance entitled
‘‘Adaptive and Other Innovative Designs
for Effectiveness Studies of New Animal
Drugs’’ have been approved under OMB
control number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21689 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
Withdrawal
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; withdrawal.
AGENCY:
The Food and Drug
Administration (FDA) is withdrawing
the notice that published in the Federal
Register of September 30, 2021, that
announced the issuance of a priority
review voucher to the sponsor of a rare
pediatric disease product application.
The Federal Register notice was
published in error and is being
withdrawn.
FOR FURTHER INFORMATION CONTACT:
Stephen Ripley, 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 September 30, 2021
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
20:38 Oct 05, 2021
Dated: October 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21823 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1402]
Biomarkers and Surrogate Endpoints
in Clinical Studies To Support
Effectiveness of New Animal Drugs;
Guidance for Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry (GFI) #267
entitled ‘‘Biomarkers and Surrogate
Endpoints in Clinical Studies to
Support Effectiveness of New Animal
Drugs.’’ The guidance describes FDA’s
current thinking with respect to
incorporating biomarkers and surrogate
endpoints into proposed clinical
investigational protocols and
applications for new animal drugs
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: The announcement of the
guidance is published in the Federal
Register on October 6, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
(86 FR 54219) in FR Doc. 2021–21311,
FDA announced the issuance of a
priority review voucher to the sponsor
of a rare pediatric disease product
application for RETHYMIC (allogeneic
processed thymus tissue-agdc),
manufactured by Enzyvant
Therapeutics, GmbH. The Federal
Register notice was published in error
and is being withdrawn.
Jkt 256001
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
55619
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–
2020–D–1402 for ‘‘Biomarkers and
Surrogate Endpoints in Clinical Studies
to Support Effectiveness of New Animal
Drugs.’’ 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
E:\FR\FM\06OCN1.SGM
06OCN1
55620
Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
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.
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:
jspears on DSK121TN23PROD with NOTICES1
Susan Storey, Center for Veterinary
Medicine (HFV–131), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0578,
susan.storey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 15,
2020 (85 FR 42879), FDA published the
notice of availability for a draft guidance
entitled ‘‘Biomarkers and Surrogate
Endpoints in Clinical Studies to
Support Effectiveness of New Animal
Drugs,’’ giving interested persons until
October 13, 2020, to comment on the
draft guidance. This final guidance
describes how the Center for Veterinary
Medicine (CVM) intends to evaluate
biomarkers, including surrogate
endpoints, when they are incorporated
into clinical investigations submitted to
CVM to demonstrate substantial
evidence of effectiveness for new animal
drug applications or a reasonable
expectation of effectiveness for
applications for conditional approval of
VerDate Sep<11>2014
20:38 Oct 05, 2021
Jkt 256001
a new animal drug. It also describes
how sponsors may obtain feedback from
CVM on technical issues related to the
use of biomarkers before the submission
of an application.
FDA received comments on the draft
guidance and those comments were
considered as the guidance was
finalized. For example, we received a
comment suggesting that we remove
from the guidance discussion of
biomarkers and a new animal drug’s
mechanism of action (MOA) with the
thought that the MOA is not a primary
endpoint and is, therefore, out of the
scope of the guidance. We revised this
section of the final guidance by adding
examples of when consideration of a
new animal drug’s MOA may be
relevant for purposes of evaluating the
use of biomarkers. We also made other
editorial changes to this final guidance
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated July 2020.
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 ‘‘Biomarkers and
Surrogate Endpoints in Clinical Studies
to Support Effectiveness of New Animal
Drugs.’’ 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 FDA’s guidance entitled
‘‘Biomarkers and Surrogate Endpoints in
Clinical Studies to Support
Effectiveness of New Animal Drugs’’
have been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21688 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1136 and FDA–
2020–D–1138]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
FDA is also announcing the withdrawal
of two FDA guidance documents related
to the COVID–19 PHE.
DATES: The announcement of the
guidances is published in the Federal
Register on October 6, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55619-55620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21688]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1402]
Biomarkers and Surrogate Endpoints in Clinical Studies To Support
Effectiveness of New Animal Drugs; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry (GFI) #267
entitled ``Biomarkers and Surrogate Endpoints in Clinical Studies to
Support Effectiveness of New Animal Drugs.'' The guidance describes
FDA's current thinking with respect to incorporating biomarkers and
surrogate endpoints into proposed clinical investigational protocols
and applications for new animal drugs under the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: The announcement of the guidance is published in the Federal
Register on October 6, 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'').
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-2020-D-1402 for ``Biomarkers and Surrogate Endpoints in Clinical
Studies to Support Effectiveness of New Animal Drugs.'' 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
[[Page 55620]]
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: Susan Storey, Center for Veterinary
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0578, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 15, 2020 (85 FR 42879), FDA
published the notice of availability for a draft guidance entitled
``Biomarkers and Surrogate Endpoints in Clinical Studies to Support
Effectiveness of New Animal Drugs,'' giving interested persons until
October 13, 2020, to comment on the draft guidance. This final guidance
describes how the Center for Veterinary Medicine (CVM) intends to
evaluate biomarkers, including surrogate endpoints, when they are
incorporated into clinical investigations submitted to CVM to
demonstrate substantial evidence of effectiveness for new animal drug
applications or a reasonable expectation of effectiveness for
applications for conditional approval of a new animal drug. It also
describes how sponsors may obtain feedback from CVM on technical issues
related to the use of biomarkers before the submission of an
application.
FDA received comments on the draft guidance and those comments were
considered as the guidance was finalized. For example, we received a
comment suggesting that we remove from the guidance discussion of
biomarkers and a new animal drug's mechanism of action (MOA) with the
thought that the MOA is not a primary endpoint and is, therefore, out
of the scope of the guidance. We revised this section of the final
guidance by adding examples of when consideration of a new animal
drug's MOA may be relevant for purposes of evaluating the use of
biomarkers. We also made other editorial changes to this final guidance
to improve clarity. The guidance announced in this notice finalizes the
draft guidance dated July 2020.
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 ``Biomarkers and Surrogate Endpoints in
Clinical Studies to Support Effectiveness of New Animal Drugs.'' 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 FDA's guidance entitled ``Biomarkers and Surrogate
Endpoints in Clinical Studies to Support Effectiveness of New Animal
Drugs'' have been approved under OMB control number 0910-0032.
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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21688 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P
