Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-Ligand 1 Blocking Antibodies for Treatment of Patients With Cancer; Guidance for Industry; Availability, 74635-74637 [2022-26464]
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<![CDATA[
Federal Register / Vol. 87, No. 233 / Tuesday, December 6, 2022 / Notices
FY 2021
reallotment
amount
Name of grant recipient that returned funds for reallotment
lotter on DSK11XQN23PROD with NOTICES1
74635
Cow Creek Band of Umpqua Tribe of Indians ..............................................................................................................................
Hopland Band of Pomo Indians ....................................................................................................................................................
Jicarilla Apache Nation ..................................................................................................................................................................
Kalispel Tribe of Indians ................................................................................................................................................................
Makah Tribe ...................................................................................................................................................................................
Muckleshoot Indian Tribe ..............................................................................................................................................................
Nooksack Indian Tribe ...................................................................................................................................................................
Paiute Indian Tribe of Utah ...........................................................................................................................................................
Quileute Tribe ................................................................................................................................................................................
Round Valley Indian Tribes ...........................................................................................................................................................
Sac and Fox Nation of Oklahoma .................................................................................................................................................
Samish Indian Nation ....................................................................................................................................................................
Shawnee Tribe ...............................................................................................................................................................................
Spokane Tribe of Indians ..............................................................................................................................................................
The Delaware Tribe of Indians ......................................................................................................................................................
7,302
1,755
16,873
7,921
31,196
37,669
38,535
61,183
1,673
558
44,538
331
3,600
19,905
15,579
Total ........................................................................................................................................................................................
323,063
The list of grant recipients that were
awarded these funds was published in
a Dear Colleague Letter that is posted to
ACF’s website at https://
www.acf.hhs.gov/ocs/resource/dearcolleagues.
Pursuant to the statute cited above,
these funds were reallotted on
September 28, 2022, to all but three
types of FFY 2022 LIHEAP grant
recipients by distributing them under
the formula that Congress set for FFY
2022 funding. The three types of
recipients that did not receive funds
were (1) those whose allocations would
have been less than $25; (2) tribes or
tribal organizations that agreed with
their co-territorial states to receive set
amounts for the entire fiscal year; and
(3) states or territories that were held to
the additional minimum floor required
by the FY 2022 appropriations act after
including the reallotment amount. No
sub-recipients of these recipients or
other entities may apply for these funds.
The reallotted funds may be used for
any purpose authorized under LIHEAP.
Grant recipients must add these funds to
their total LIHEAP funds payable for
FFY 2022 for purposes of calculating
statutory caps on administrative costs,
carryover, Assurance 16 activities, and
weatherization assistance. Grant
recipients must also (1) ensure that
these funds are included in the amounts
that ACF pre-populated on Line 1.1 of
their FFY 2022 Carryover and
Reallotment Reports; (2) reconcile these
funds, to the extent that they received
them, on a separate Federal Financial
Form (SF–425); and (3) record, on their
FFY 2022 Household Reports,
households that receive benefits at least
partly from these funds. State recipients
must also ensure that these funds are
included in the Grantee Survey sections
VerDate Sep<11>2014
17:51 Dec 05, 2022
Jkt 259001
of their FFY 2022 LIHEAP Performance
Data Forms.
OCS recommends that, after receiving
them, grant recipients obligate these
funds before obligating any other federal
LIHEAP funds.
Statutory Authority: 42 U.S.C.
8626(b).
Karen D. Shields,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
[FR Doc. 2022–26447 Filed 12–5–22; 8:45 am]
BILLING CODE 4184–80–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0691]
Pharmacokinetic-Based Criteria for
Supporting Alternative Dosing
Regimens of Programmed Cell Death
Receptor-1 or Programmed Cell DeathLigand 1 Blocking Antibodies for
Treatment of Patients With Cancer;
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 entitled
‘‘Pharmacokinetic-Based Criteria for
Supporting Alternative Dosing
Regimens of Programmed Cell Death
Receptor-1 (PD-1) or Programmed Cell
Death-Ligand 1 (PD-L1) Blocking
Antibodies for Treatment of Patients
with Cancer.’’ This guidance provides
recommendations for sponsors of
investigational new drug applications
(INDs) and biologics license
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
applications (BLAs) on the use of
pharmacokinetic (PK)-based criteria to
support the approval of alternative
dosing regimens for programmed cell
death receptor-1 (PD-1) or programmed
cell death-ligand 1 (PD-L1) blocking
antibodies. This guidance is based on
accumulated scientific and regulatory
experience for PD-1 and PD-L1 drugs,
and as such, does not address
development of alternative dosing
regimens for other drugs or biologics,
changes in route of administration, or
novel formulations of previously
approved PD-1/PD-L1 products. This
guidance finalizes the draft guidance of
the same title issued on August 26,
2021.
DATES: The announcement of the
guidance is published in the Federal
Register on December 6, 2022.
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
E:\FR\FM\06DEN1.SGM
06DEN1
74636
Federal Register / Vol. 87, No. 233 / Tuesday, December 6, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
2021–D–0691 for ‘‘PharmacokineticBased Criteria for Supporting
Alternative Dosing Regimens of
Programmed Cell Death Receptor-1 (PD1) or Programmed Cell Death-Ligand 1
(PD-L1) Blocking Antibodies for
Treatment of Patients with Cancer.’’
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
VerDate Sep<11>2014
17:51 Dec 05, 2022
Jkt 259001
‘‘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 this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. 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:
Brian Booth, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Avenue, Building 51, Silver Spring, MD
20993, 301–796–1508.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Pharmacokinetic-Based Criteria for
Supporting Alternative Dosing
Regimens of Programmed Cell Death
Receptor-1 (PD-1) or Programmed Cell
Death-Ligand 1 (PD-L1) Blocking
Antibodies for Treatment of Patients
with Cancer.’’ This guidance provides
recommendations for sponsors of INDs
and BLAs on the use of PK-based
criteria to support the approval of
alternative dosing regimens for PD-1 or
PD-L1 blocking antibodies. The
guidance is based on accumulated
scientific and regulatory experience for
PD-1 and PD-L1 drugs, as such, does not
address development of alternative
dosing regimens for any other drugs or
biologics, changes in route of
administration, or novel formulations of
previously approved PD-1/PD-L1
products.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Sponsors may seek approval of
alternative intravenous (IV) dosing
regimens that are different from those
tested in the original clinical efficacy
and safety trials that served as the basis
of approval of the current dosing
regimen, or in the pre-approval setting,
dosing regimens that differ from those
tested in earlier PK and efficacy studies
conducted during development. These
alternative IV dosing regimens are
typically designed to change doses and
dosing intervals. Longer dosing intervals
can minimize patient burden and
reduce risks associated with more
frequent administration (e.g., infusion
reactions), as well as exposure to
communicable diseases (e.g., SARS–
CoV–2) associated with visits to
hospitals or infusion centers. The
guidance describes the criteria for using
the PK-based approach and the
documents that should be included in
the submissions seeking approval.
This guidance finalizes the draft
guidance of the same title issued on
August 26, 2021 (86 FR 47649). FDA
considered comments received on the
draft guidance as it finalized the
guidance. Changes from the draft to the
final guidance include: (1) PK-based
approach to support approval of
alternative dosing regimens for PD-1/
PD-L1 blocking antibody products may
apply to pre- and post-approval setting
and (2) this approach may apply to PD1/PD-L1 monotherapies and
combination regimens where the dose
and/or dose schedule of the PD-1/PD-L1
is the only proposed change. In
addition, editorial changes were made
to improve clarity.
This 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 ‘‘PharmacokineticBased Criteria for Supporting
Alternative Dosing Regimens of
Programmed Cell Death Receptor-1 (PD1) or Programmed Cell Death-Ligand 1
(PD-L1) Blocking Antibodies for
Treatment of Patients with Cancer.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use another 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
E:\FR\FM\06DEN1.SGM
06DEN1
Federal Register / Vol. 87, No. 233 / Tuesday, December 6, 2022 / Notices
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; and the collections
of information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26464 Filed 12–5–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1828]
E19 A Selective Approach to Safety
Data Collection in Specific Late-Stage
Pre-Approval or Post-Approval Clinical
Trials; International Council for
Harmonisation; 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 entitled ‘‘E19 A
Selective Approach to Safety Data
Collection in Specific Late-Stage Preapproval or Post-Approval Clinical
Trials.’’ The final guidance was
prepared under the auspices of the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use (ICH),
formerly the International Conference
on Harmonisation. The guidance revises
the draft guidance for industry entitled
‘‘E19 Optimisation of Safety Data
Collection’’ issued in June 2019. The
final guidance provides
recommendations regarding appropriate
use of a selective approach to safety data
collection in some late-stage pre- or
post-marketing studies of drugs where
the safety profile, with respect to
commonly occurring adverse events, is
well understood and documented. The
final guidance is intended to advance
important clinical research questions
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:51 Dec 05, 2022
Jkt 259001
through the conduct of clinical
investigations that collect relevant
patient data, which will enable an
adequate benefit-risk assessment of the
drug for its intended use, while
reducing the burden to patients from
unnecessary tests that may yield limited
additional information.
DATES: The announcement of the
guidance is published in the Federal
Register on December 6, 2022.
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–
2019–D–1828 for ‘‘E19 A Selective
Approach to Safety Data Collection in
Specific Late-Stage Pre-approval or Post-
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
74637
Approval Clinical Trials.’’ 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.
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 this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
E:\FR\FM\06DEN1.SGM
06DEN1
]]>Agencies
[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74635-74637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26464]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0691]
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing
Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-
Ligand 1 Blocking Antibodies for Treatment of Patients With Cancer;
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 entitled
``Pharmacokinetic-Based Criteria for Supporting Alternative Dosing
Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell
Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients
with Cancer.'' This guidance provides recommendations for sponsors of
investigational new drug applications (INDs) and biologics license
applications (BLAs) on the use of pharmacokinetic (PK)-based criteria
to support the approval of alternative dosing regimens for programmed
cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1)
blocking antibodies. This guidance is based on accumulated scientific
and regulatory experience for PD-1 and PD-L1 drugs, and as such, does
not address development of alternative dosing regimens for other drugs
or biologics, changes in route of administration, or novel formulations
of previously approved PD-1/PD-L1 products. This guidance finalizes the
draft guidance of the same title issued on August 26, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on December 6, 2022.
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
[[Page 74636]]
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-2021-D-0691 for ``Pharmacokinetic-Based Criteria for Supporting
Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1)
or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for
Treatment of Patients with Cancer.'' 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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Brian Booth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 51, Silver Spring, MD 20993, 301-796-1508.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Pharmacokinetic-Based Criteria for Supporting Alternative
Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or
Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for
Treatment of Patients with Cancer.'' This guidance provides
recommendations for sponsors of INDs and BLAs on the use of PK-based
criteria to support the approval of alternative dosing regimens for PD-
1 or PD-L1 blocking antibodies. The guidance is based on accumulated
scientific and regulatory experience for PD-1 and PD-L1 drugs, as such,
does not address development of alternative dosing regimens for any
other drugs or biologics, changes in route of administration, or novel
formulations of previously approved PD-1/PD-L1 products.
Sponsors may seek approval of alternative intravenous (IV) dosing
regimens that are different from those tested in the original clinical
efficacy and safety trials that served as the basis of approval of the
current dosing regimen, or in the pre-approval setting, dosing regimens
that differ from those tested in earlier PK and efficacy studies
conducted during development. These alternative IV dosing regimens are
typically designed to change doses and dosing intervals. Longer dosing
intervals can minimize patient burden and reduce risks associated with
more frequent administration (e.g., infusion reactions), as well as
exposure to communicable diseases (e.g., SARS-CoV-2) associated with
visits to hospitals or infusion centers. The guidance describes the
criteria for using the PK-based approach and the documents that should
be included in the submissions seeking approval.
This guidance finalizes the draft guidance of the same title issued
on August 26, 2021 (86 FR 47649). FDA considered comments received on
the draft guidance as it finalized the guidance. Changes from the draft
to the final guidance include: (1) PK-based approach to support
approval of alternative dosing regimens for PD-1/PD-L1 blocking
antibody products may apply to pre- and post-approval setting and (2)
this approach may apply to PD-1/PD-L1 monotherapies and combination
regimens where the dose and/or dose schedule of the PD-1/PD-L1 is the
only proposed change. In addition, editorial changes were made to
improve clarity.
This 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 ``Pharmacokinetic-Based Criteria for
Supporting Alternative Dosing Regimens of Programmed Cell Death
Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking
Antibodies for Treatment of Patients with Cancer.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use another 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
[[Page 74637]]
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; and the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26464 Filed 12-5-22; 8:45 am]
BILLING CODE 4164-01-P
