Notice of Closed Meeting, 69651-69652 [2021-26575]
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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: December 2, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–26561 Filed 12–7–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meetings
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of five AHRQ
Subcommittee meetings.
AGENCY:
The subcommittees listed
below are part of AHRQ’s Health
Services Research Initial Review Group
Committee. Grant applications are to be
reviewed and discussed at these
meetings. Each subcommittee meeting
will be closed to the public.
DATES: See below for dates of meetings:
1. Healthcare Safety and Quality
Improvement Research (HSQR)
Date: February 2–3, 2022
2. Healthcare Effectiveness and
Outcomes Research (HEOR)
Date: February 9–10, 2022
3. Health System and Value Research
(HSVR)
Date: February 10–11, 2022
4. Healthcare Research Training (HCRT)
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SUMMARY:
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Date: February 24–25–28, 2022
5. Healthcare Information Technology
Research (HITR)
Date: February 24–25, 2022
ADDRESSES: Agency for Healthcare
Research and Quality (Virtual Review),
5600 Fishers Lane, Rockville, Maryland
20857.
FOR FURTHER INFORMATION CONTACT: (to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of the meetings.) Jenny Griffith,
Committee Management Officer, Office
of Extramural Research Education and
Priority Populations, Agency for
Healthcare Research and Quality
(AHRQ), 5600 Fishers Lane, Rockville,
Maryland 20857, Telephone (301) 427–
1557.
SUPPLEMENTARY INFORMATION: In
accordance with section 10 (a)(2) of the
Federal Advisory Committee Act (5
U.S.C. App. 2), AHRQ announces
meetings of the above-listed scientific
peer review groups, which are
subcommittees of AHRQ’s Health
Services Research Initial Review Group
Committee. The subcommittee meetings
will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. App. 2 section 10(d), 5
U.S.C. 552b(c)(4), and 5 U.S.C.
552b(c)(6). 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.
Agenda items for these meetings are
subject to change as priorities dictate.
Marquita Cullom,
Associate Director.
69651
Operating Officer, CDC, pursuant to
Public Law 92–463. 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: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–CE–22–004, Research Grants to
Prevent Firearm-Related Violence and
Injuries.
Dates: April 4–8, 2022.
Times: 8:30 a.m.–5:00 p.m., EDT.
Place: Videoconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Mikel Walters, Ph.D., Scientific Review
Officer, National Center for Injury
Prevention and Control, CDC, 4770
Buford Highway NE, Mailstop F–63,
Atlanta, Georgia 30341–3717,
Telephone: (404) 639–0913; Email:
MWalters@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–26576 Filed 12–7–21; 8:45 am]
[FR Doc. 2021–26545 Filed 12–7–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
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69652
Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices
Public Law 92–463. 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: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)–
RFA–OH–22–003, Occupational Safety
and Health Training Project Grants.
Date: February 1–2, 2022.
Time: 1:00 p.m.–4:00 p.m., EST.
Place: Video-Assisted Meeting.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Marilyn Ridenour, B.S.N., M.P.H.,
Scientific Review Officer, Office of
Extramural Programs, National Institute
for Occupational Safety and Health,
CDC, 1095 Willowdale Road,
Morgantown, West Virginia 26505,
Telephone: (304) 285–5879; Email:
MRidenour@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Notice of availability.
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’’).
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
Written/Paper Submissions
Submit written/paper submissions as
follows:
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–26575 Filed 12–7–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1140]
jspears on DSK121TN23PROD with NOTICES1
guidance for sponsor-investigators
entitled ‘‘IND Submissions for
Individualized Antisense
Oligonucleotide Drug Products for
Severely Debilitating or LifeThreatening Diseases: Clinical
Recommendations.’’ FDA is publishing
this draft guidance to provide sponsorinvestigators (hereafter referred to as
sponsors) who are interested in
developing individualized antisense
oligonucleotide (ASO) drug products for
a rapidly progressive, severely
debilitating, or life-threatening (SDLT)
genetic disease (caused by a unique
genetic variant or variants), with clinical
recommendations for submission of
investigational new drug applications
(INDs). These recommendations
specifically address the following
clinical considerations: Ethical and
human subject protection, diagnostic
and genetic, dosing, administration,
safety, and assessment of clinical
response to treatment.
DATES: Submit either electronic or
written comments on the draft guidance
by February 7, 2022 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:
Investigational New Drug Application
Submissions for Individualized
Antisense Oligonucleotide Drug
Products for Severely Debilitating or
Life-Threatening Diseases: Clinical
Recommendations; Draft Guidance for
Sponsor-Investigators; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
SUMMARY:
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• 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–1140 for ‘‘IND Submissions for
Individualized Antisense
Oligonucleotide Drug Products for
Severely Debilitating or LifeThreatening Diseases: Clinical
Recommendations.’’ 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
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-201509-18/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
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]]>Agencies
[Federal Register Volume 86, Number 233 (Wednesday, December 8, 2021)]
[Notices]
[Pages 69651-69652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26575]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
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, and the Determination of the Director, Strategic
Business Initiatives Unit, Office of the Chief Operating Officer, CDC,
pursuant to
[[Page 69652]]
Public Law 92-463. 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: Disease, Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)-RFA-OH-22-003, Occupational Safety
and Health Training Project Grants.
Date: February 1-2, 2022.
Time: 1:00 p.m.-4:00 p.m., EST.
Place: Video-Assisted Meeting.
Agenda: To review and evaluate grant applications.
For Further Information Contact: Marilyn Ridenour, B.S.N., M.P.H.,
Scientific Review Officer, Office of Extramural Programs, National
Institute for Occupational Safety and Health, CDC, 1095 Willowdale
Road, Morgantown, West Virginia 26505, Telephone: (304) 285-5879;
Email: [email protected].
The Director, Strategic Business Initiatives Unit, Office of the
Chief Operating Officer, Centers for Disease Control and Prevention,
has been delegated the authority to sign Federal Register notices
pertaining to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention and
the Agency for Toxic Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2021-26575 Filed 12-7-21; 8:45 am]
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