[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47649-47650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18317]


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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; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 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 This draft guidance provides recommendations for 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 This draft guidance is based on 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 any other drugs or biologics, changes in route of 
administration, or novel formulations of previously approved PD-1/PD-L1 
products.

DATES: Submit either electronic or written comments on the draft 
guidance by October 25, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-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

[[Page 47650]]

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 draft 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 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Brian Booth, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2186, Silver Spring, MD 20993, 301-796-
1508.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 draft 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 draft 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 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 clinical efficacy and 
safety trials. These alternative IV dosing regimens are typically 
designed to change doses (e.g., body weight adjusted doses to flat 
doses) and/or dosing intervals (e.g., once every 3 weeks to once every 
6 weeks). Longer dosing interval periods 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 draft guidance describes the criteria for using the PK-
based approach and the documents that should be included in the 
submissions seeking approval.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 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 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 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either 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: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18317 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P


