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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices circulatory-system-devices-panel. Select the link for the 2021 Meeting Materials.
The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 21, 2021.
Oral presentations from the public will be scheduled on November 2 and November 3, 2021, between approximately 1 p.m. and 2 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person see FOR
FURTHER INFORMATION CONTACT. The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, the date which they want to present, and an indication of the approximate time requested to make their presentation on or before October 13, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 14, 2021.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Artair Mallett at Artair.Mallett@fda.hhs.gov or 301
7969638 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https www.fda.gov/advisorycommittees/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act 5
U.S.C. app. 2.

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Dated: August 20, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118403 Filed 82521; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021D0691

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;
Draft 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 draft guidance for industry entitled Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 PD1 or Programmed Cell Death-Ligand 1 PDL1 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 PD1 or programmed cell death-ligand 1 PDL1 blocking antibodies. This draft guidance is based on accumulated scientific and regulatory experience for PD1 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 PD1/PDL1
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:
SUMMARY:

Electronic Submissions Submit electronic comments in the following way:

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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 elses 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 HFA305, 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
2021D0691 for PharmacokineticBased Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 PD
1 or Programmed Cell Death-Ligand 1
PDL1 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, 2404027500.
Confidential SubmissionsTo 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
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