Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 47649 

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 301–796–4540. 

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– 

796–9638 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). 

Dated: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18403 Filed 8–25–21; 8:45 am] 

BILLING CODE 4164–01–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; 

Draft 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 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 ‘‘PharmacokineticBased 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 


jbell on DSKJLSW7X2PROD with NOTICES
47650 Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 

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 PKbased 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/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Infant Mortality 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Infant Mortality (ACIM or 

Committee) has scheduled a public 

meeting. Information about ACIM and 

the agenda for this meeting can be found 

on the ACIM website at https://

www.hrsa.gov/advisory-committees/ 

infant-mortality/index.html. 

DATES: September 21, 2021, 12:00 p.m.– 

4:00 p.m. Eastern Time and September 

22, 2021, 12:00 p.m.–4:00 p.m. Eastern 

Time. 

ADDRESSES: This meeting will be held 

via webinar. The webinar link and login information will be available at 

ACIM’s website before the meeting: 

https://www.hrsa.gov/advisorycommittees/infant-mortality/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Lee, MPH, Designated Federal 

Official, Maternal and Child Health 

Bureau, HRSA, 5600 Fishers Lane, 

Room 18N84, Rockville, Maryland 

20857; (301) 443–0543; or SACIM@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACIM is 

authorized by section 222 of the Public 

Health Service Act (42 U.S.C. 217a), as 

amended. The Committee is governed 


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