Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 315-316 [2020-29141]
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Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices
FOR FURTHER INFORMATION CONTACT:
jbell on DSKJLSW7X2PROD with NOTICES
Colleen Locicero, Office of New Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Avenue, Silver Spring, MD 20903, 301–
796–1114.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘IND Submissions for Individualized
Antisense Oligonucleotide Drug
Products: Administrative and
Procedural Recommendations.’’ This
draft guidance is intended to help
sponsors developing individualized
ASO drug products for a severely
debilitating or life-threatening genetic
disease.
The draft guidance addresses the
approach for obtaining feedback from
FDA, the expectations and process for
making regulatory submissions to FDA,
and high-level recommendations related
to the requirement for institutional
review board review of protocols for
trials of individualized ASO drug
products and the informed consent of
participants. The draft guidance
discusses the importance of early
interaction with FDA, submission
expectations for pre-investigational new
drug (IND) meeting packages and IND
applications, and ethical and human
subject protection considerations.
The draft guidance is intended to help
sponsors of such development
programs, who may be relatively
unfamiliar with FDA regulations,
processes, and practices, seek feedback
from FDA on their development
programs and make regulatory
submissions related to these
development programs. The draft
guidance is expected to facilitate the
preparation of adequate pre-IND and
IND submissions for review by the
Agency, which may help enable prompt
initiation of the investigation.
This draft guidance represents the
first of several guidances FDA intends to
publish to advise and help sponsors
developing individualized ASO drug
products for patients who have severely
debilitating or life-threatening diseases
or conditions and no adequate
alternative therapy available to them to
treat their disease or condition.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘IND Submissions for Individualized
Antisense Oligonucleotide Drug
Products: Administrative and
Procedural Recommendations.’’ It does
VerDate Sep<11>2014
17:09 Jan 04, 2021
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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 (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 for the
submission of IND applications,
amendments, and safety reports; for
investigator brochures; and for
requesting a pre-IND meeting have been
approved under OMB control number
0910–0014; the collections of
information for paper submissions of
Form FDA 3500A have been approved
under OMB control number 0910–0291;
the collections of information for
electronic submissions of Form FDA
3500 have been approved under OMB
control number 0910–0645; the
collections of information in 21 CFR
parts 50 and 56 for obtaining informed
consent for prospective patients have
been approved under OMB control
number 0910–0755.
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 or https://
www.regulations.gov.
Dated: December 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–29119 Filed 1–4–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council provides advice on
how to prevent or reduce the burden of
SUMMARY:
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315
Alzheimer’s disease and related
dementias on people with the disease
and their caregivers. During the January
25, 2021 meeting the Advisory Council
will hear presentations on the impact of
COVID–19 on people with dementia,
health disparities in dementia research,
and the implications of new
technologies to identify Alzheimer’s
disease through a blood tests.
DATES: The meeting will be held on
January 25, 2021 from 1:00 p.m. to 4:30
p.m. EST.
ADDRESSES: The meeting will be virtual,
streaming at https://www.hhs.gov/live.
Comments: Time is allocated on the
agenda to hear public comments from
4:00 p.m. to 4:30 p.m. The time for oral
comments will be limited to two (2)
minutes per individual. In order to
provide a public comment, please
register by emailing your name to
napa@hhs.gov by Thursday, January 21.
Registered commenters will receive both
a dial-in number and a link to join the
meeting virtually; individuals will have
the choice to either join virtually via the
link, or to call in only by using the dialin number. Note: There may be a 30–45
second delay in the livestream video
presentation of the conference. For this
reason, if you have pre-registered to
submit a public comment, it is
important to connect to the meeting by
3:45 p.m. to ensure that you do not miss
your name and allotted time when
called. If you miss your name and
allotted time to speak, you may not be
able to make your public comment. All
participant audio lines will be muted for
the duration of the meeting and only
unmuted by the Host at the time of the
participant’s public comment. Should
you have questions during the session
email napa@hhs.gov and someone will
respond to your message as quickly as
possible.
In order to ensure accuracy, please
submit a written copy of oral comments
for the record by emailing napa@
hhs.gov by Tuesday, January 26. These
comments will be shared on the website
and reflected in the meeting minutes.
In lieu of oral comments, formal
written comments may be submitted for
the record by Tuesday, January 26 to
Helen Lamont, Ph.D., OASPE, 200
Independence Avenue SW, Room 424E,
Washington, DC 20201. Comments may
also be sent to napa@hhs.gov. Those
submitting written comments should
identify themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: The
meeting will be available to the public
live at www.hhs.gov/live.
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316
Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices
Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: Impact of
COVID–19 on people with dementia,
health disparities in dementia research,
and the implications of new
technologies to identify Alzheimer’s
disease through a blood tests.
Procedure and Agenda: The meeting
will be webcast at www.hhs.gov/live and
video recordings will be added to the
National Alzheimer’s Project Act
website when available, after the
meeting.
SUPPLEMENTARY INFORMATION:
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: December 21, 2020.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2020–29141 Filed 1–4–21; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
Name of Committee: Board of Scientific
Counselors, NHLBI.
Date: February 1, 2021.
Time: 8:45 a.m. to 6:00 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 10, 10 Center Drive, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Robert S. Balaban, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institutes of Health,
Jkt 253001
Dated: December 29, 2020.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Heart, Lung, and Blood
Institute, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
17:09 Jan 04, 2021
Date: March 10–12, 2021.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Video
Meeting).
Contact Person: Charlene J. Repique, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7347, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–7791,
charlene.repique@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: December 29, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–29148 Filed 1–4–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute on Aging; Notice of
Closed Meeting
[FR Doc. 2020–29124 Filed 1–4–21; 8:45 am]
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
VerDate Sep<11>2014
NHLBI Building 10, CRC, 4th Floor, Room
1581, 10 Center Drive, Bethesda, MD 20892,
(301) 496–2116, balabanr@nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group; Diabetes,
Endocrinology and Metabolic Diseases DDK–
B Subcommittee.
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Preclinical
Development of Aging Therapeutics.
Date: February 18, 2021.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Birgit Neuhuber, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, 7201 Wisconsin Avenue,
Gateway Building, Suite 2W200, Bethesda,
MD 20892, (301) 480–1266, neuhuber@
ninds.nih.gov.
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]]>Agencies
[Federal Register Volume 86, Number 2 (Tuesday, January 5, 2021)]
[Notices]
[Pages 315-316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29141]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Council on Alzheimer's Research, Care, and Services;
Meeting
AGENCY: Assistant Secretary for Planning and Evaluation, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the public meeting of the Advisory
Council on Alzheimer's Research, Care, and Services (Advisory Council).
The Advisory Council provides advice on how to prevent or reduce the
burden of Alzheimer's disease and related dementias on people with the
disease and their caregivers. During the January 25, 2021 meeting the
Advisory Council will hear presentations on the impact of COVID-19 on
people with dementia, health disparities in dementia research, and the
implications of new technologies to identify Alzheimer's disease
through a blood tests.
DATES: The meeting will be held on January 25, 2021 from 1:00 p.m. to
4:30 p.m. EST.
ADDRESSES: The meeting will be virtual, streaming at https://www.hhs.gov/live.
Comments: Time is allocated on the agenda to hear public comments
from 4:00 p.m. to 4:30 p.m. The time for oral comments will be limited
to two (2) minutes per individual. In order to provide a public
comment, please register by emailing your name to [email protected] by
Thursday, January 21. Registered commenters will receive both a dial-in
number and a link to join the meeting virtually; individuals will have
the choice to either join virtually via the link, or to call in only by
using the dial-in number. Note: There may be a 30-45 second delay in
the livestream video presentation of the conference. For this reason,
if you have pre-registered to submit a public comment, it is important
to connect to the meeting by 3:45 p.m. to ensure that you do not miss
your name and allotted time when called. If you miss your name and
allotted time to speak, you may not be able to make your public
comment. All participant audio lines will be muted for the duration of
the meeting and only unmuted by the Host at the time of the
participant's public comment. Should you have questions during the
session email [email protected] and someone will respond to your message as
quickly as possible.
In order to ensure accuracy, please submit a written copy of oral
comments for the record by emailing [email protected] by Tuesday, January
26. These comments will be shared on the website and reflected in the
meeting minutes.
In lieu of oral comments, formal written comments may be submitted
for the record by Tuesday, January 26 to Helen Lamont, Ph.D., OASPE,
200 Independence Avenue SW, Room 424E, Washington, DC 20201. Comments
may also be sent to [email protected]. Those submitting written comments
should identify themselves and any relevant organizational
affiliations.
FOR FURTHER INFORMATION CONTACT: Helen Lamont, 202-260-6075,
[email protected]. Note: The meeting will be available to the public
live at www.hhs.gov/live.
[[Page 316]]
SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: Impact of COVID-19 on people with
dementia, health disparities in dementia research, and the implications
of new technologies to identify Alzheimer's disease through a blood
tests.
Procedure and Agenda: The meeting will be webcast at www.hhs.gov/live and video recordings will be added to the National Alzheimer's
Project Act website when available, after the meeting.
Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National
Alzheimer's Project Act. The panel is governed by provisions of
Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of advisory committees.
Dated: December 21, 2020.
Brenda Destro,
Deputy Assistant Secretary for Planning and Evaluation, Office of Human
Services Policy.
[FR Doc. 2020-29141 Filed 1-4-21; 8:45 am]
BILLING CODE 4150-05-P
