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copies of the draft guidance to the 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access to the draft guidance document.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a draft guidance for industry entitled 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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 47651 

by provisions of Public Law 92–463, as 

amended, (5 U.S.C. app. 2), which sets 

forth standards for the formation and 

use of Advisory Committees. 

ACIM advises the Secretary of Health 

and Human Services on department 

activities and programs directed at 

reducing infant mortality and improving 

the health status of pregnant women 

and infants. ACIM represents a publicprivate partnership at the highest level 

to provide guidance and focus attention 

on the policies and resources required 

to address the reduction of infant 

mortality and the improvement of the 

health status of pregnant women and 

infants. With a focus on life course, the 

ACIM addresses disparities in maternal 

health to improve maternal health 

outcomes, including preventing and 

reducing maternal mortality and severe 

maternal morbidity. ACIM provides 

advice on how best to coordinate 

myriad federal, state, local, and private 

programs and efforts that are designed 

to deal with the health and social 

problems impacting infant mortality and 

maternal health, including 

implementation of the Healthy Start 

program and maternal and infant health 

objectives from the National Health 

Promotion and Disease Prevention 

Objectives (i.e., Healthy People 2030). 

The agenda for the September 21–22, 

2021, meeting is being finalized and 

may include the following topics: 

Federal program updates; discussion of 

recommendations by ACIM to the 

Secretary; fatality review programs; 

health of indigenous mothers and 

infants; financing of care; and patientphysician racial concordance in health 

care. Refer to the ACIM website for any 

updated information concerning the 

meeting. 

Members of the public will have the 

opportunity to provide written or oral 

comments. Requests to submit a written 

statement or make oral comments to the 

ACIM should be sent to Vanessa Lee, 

using the email address above at least 

three business days prior to the meeting. 

Public participants may submit written 

statements in advance of the scheduled 

meeting by emailing SACIM@hrsa.gov. 

Oral comments will be honored in the 

order they are requested and may be 

limited as time allows. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Vanessa Lee at the contact 

information listed above at least 10 

business days prior to the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–18378 Filed 8–25–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Advisory 

Dental and Craniofacial Research 

Council, September 9, 2021, 10:00 a.m. 

to September 9, 2021, 4:00 p.m., 

National Institutes of Health, National 

Institute of Dental and Craniofacial Res., 

6701 Democracy Blvd., Bethesda, MD 

20892 which was published in the 

Federal Register on August 13, 2021, FR 

Doc. 2021–17302, 86 FR 44736. 

This meeting is being amended to 

change the times of the Open and 

Closed sessions. The Open session will 

be from 9:00 a.m. to 2:30 p.m. and will 

be videocast and can be accessed from 

the NIH Videocasting and Podcasting 

website (http://videocast.nih.gov/). The 

Closed session will be from 2:45 p.m. to 

3:30 p.m. The meeting is partially 

Closed to the public. 

Dated: August 23, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–18401 Filed 8–25–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request Electronic 

Individual Development Plan (eIDP) 

(National Eye Institute) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Dr. Cesar E. Perez-Gonzalez, 

Training Director, Office of the 

Scientific Director, National Eye 

Institute, NIH, Building 31, Room 6A22, 

MSC 0250, Bethesda, Maryland 20892 

or call non-toll-free number (301) 451– 

6763 or Email your request, including 

your address to: cesarp@nei.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on May 24, 2021, page 27856– 

27857 (86 FR 27856) and allowed 60 

days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

The National Eye Institute (NEI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

Proposed Collection: Electronic 

Individual Development Plans, 0925– 

NEW, XX/XX/XXXX, National Eye 

Institute (NEI), National Institutes of 

Health (NIH). 

Need and Use of Information 

Collection: The National Eye Institute’s 

(NEI) Office of the Scientific Director 

(OSD) goal is to train the next 

generation of vision researchers and 

ophthalmologists. Trainees who 

participate in NEI research come with 

different levels of education (student, 

postbaccalaureate, predoctoral 

including graduate and medical 

students, postdoctoral fellows) and for 

different amounts of time (6 months to 

5 years). Training at the NEI focuses on 

scientific and professional skill 

development. To enhance their chances 

of obtaining their ideal career, 

completing an annual Individual 


jbell on DSKJLSW7X2PROD with NOTICES