Meeting of the Advisory Committee on Infant Mortality, 47650-47651 [2021-18378]
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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a draft guidance for industry entitled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
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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 This draft guidance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 The draft
guidance is based on accumulated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
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Sponsors may seek approval of
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regimens are typically designed to
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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 The draft
guidance describes the criteria for using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This draft guidance is being issued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The draft guidance, when finalized, will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
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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
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Infant Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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/.
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/.
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.
SUMMARY:
ACIM is
authorized by section 222 of the Public
Health Service Act (42 U.S.C. 217a), as
amended. The Committee is governed
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
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]
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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 (https://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]
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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.
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.
SUMMARY:
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/
ADDRESSES:
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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
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Agencies
[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47650-47651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18378]
-----------------------------------------------------------------------
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/.
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
log-in information will be available at ACIM's website before the
meeting: https://www.hrsa.gov/advisory-committees/infant-mortality/.
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
[email protected].
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
[[Page 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 public-private 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 patient-physician 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 [email protected]. 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]
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