Center for Substance Abuse Treatment; Notice of Meeting, 10107-10108 [2021-03269]
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10107
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
The DUA legally binds the user to the
Agreement’s terms. The user must agree
to all the terms and sign off on them
prior to the release or access to data files
containing protected health information,
and individual identifiers. The DMP
SAQ is a technical, evidence-based
questionnaire that DUA users must
complete as part of the data request
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to evaluate researcher data systems to
ensure that CMS data are adequately
secured and appropriately protected, as
per the Privacy Act and the HIPAA
Privacy Rule. The DMP SAQ also allows
CMS to measure compliance through
the implementation of security and
privacy controls as outlined in the
National Institute of Standards and
Technology (NIST) Special Publication
800–53 and the Centers for Medicare &
Medicaid Services (CMS) Information
Security and Acceptable Risk
Safeguards (ARS). The second
component of the DMP SAQ is to
provide ongoing oversight. All
organizations will be subject to routine
audits of the environments used to store
and process CMS data, as described in
their organizational-level DMP SAQ.
Form Number: CMS–10733 (OMB
control number: 0938-New); Frequency:
Annually; Affected Public: Private
Sector, State, Local, or Tribal
Governments, Federal Government,
Business or other for-profits, Not-forprofits institutions; Number of
Respondents: 1,000; Total Annual
Responses: 1,000; Total Annual Hours:
1,500. (For policy questions regarding
this collection contact James Krometis at
410–786–0340.)
Dated: February 12, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–03260 Filed 2–17–21; 8:45 am]
BILLING CODE 4120–01–P
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–N–1027, FDA–
2017–N–1064, FDA–2009–N–0380, FDA–
2010–N–0588, FDA–2014–N–0487, and FDA–
2013–N–1429]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Infant Formula Recall Regulations ..........................................................................................................................
State Petitions for Exemption from Preemption ......................................................................................................
Product Jurisdiction and Combination Products .....................................................................................................
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile ......
Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery ........................................................................................................................................................................
Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FFDCA and Associated Fees Under Section 744K .....................................................................................................................
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03254 Filed 2–17–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Substance Abuse and Mental Health
Services Administration
Center for Substance Abuse
Treatment; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
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Center for Substance Abuse Treatment
(CSAT) National Advisory Council
(NAC) will meet on March 31, 2021,
1:00 p.m.–6:00 p.m. (EDT).
The meeting is open to the public and
will include consideration of minutes
from the SAMHSA CSAT NAC meeting
of September 22, 2020; an update on
CSAT activities; a discussion with
SAMHSA leadership; a discussion about
the use of technology in prevention and
treatment of substance use disorders;
and a discussion on rural and frontier
communities.
The meeting will be held via WebEx
and telephone only. Interested persons
may present data, information, or views,
orally or in writing, on issues pending
before the Council. Oral presentations
from the public will be scheduled at the
PO 00000
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Date approval
expires
0910–0188
0910–0277
0910–0523
0910–0614
12/31/2023
12/31/2023
12/31/2023
12/31/2023
0910–0697
12/31/2023
0910–0776
12/31/2023
conclusion of the meeting. Individuals
interested in making oral presentations
or written submissions must notify the
contact person on or before March 19,
2021. Up to five minutes will be allotted
for each presentation.
Registration is required to participate.
To attend virtually, or to obtain the callin number and access code, submit
written or brief oral comments, or
request special accommodations for
persons with disabilities, please register
on-line at https://snacregister.
samhsa.gov/MeetingList.aspx, or
communicate with the CSAT National
Advisory Council Designated Federal
Officer; (see contact information below).
Meeting information and a roster of
Council members may be obtained by
accessing the SAMHSA Committee
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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
website at https://www.samhsa.gov/
about-us/advisory-councils/csatnational-advisory-council or by
contacting the CSAT National Advisory
Council Designated Federal Officer.
Council Name: SAMHSA’s Center for
Substance Abuse Treatment, National
Advisory Council.
Date/Time/Type: March 31, 2021,
1:00 p.m.–6:00 p.m. EDT, OPEN.
Place: SAMHSA, 5600 Fishers Lane,
Rockville, Maryland 20857.
Contact: Tracy Goss, Designated
Federal Officer, CSAT National
Advisory Council, 5600 Fishers Lane,
Rockville, Maryland 20857 (mail),
Telephone: (240) 276–0759, Email:
tracy.goss@samhsa.hhs.gov.
Dated: February 11, 2021.
Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2021–03269 Filed 2–17–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0803]
Advisory Committee; Technical
Electronic Product Radiation Safety
Standards Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Technical Electronic
Product Radiation Safety Standards
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Technical Electronic Product Radiation
Safety Standards Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the December 24, 2022,
expiration date.
DATES: Authority for the Technical
Electronic Product Radiation Safety
Standards Committee (the Committee)
will expire on December 24, 2022,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring,
MD 20993–0002, 301–796–6875, email:
Patricio.Garcia@fda.hhs.gov.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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17:47 Feb 17, 2021
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Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Committee. The Committee is a nondiscretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Commissioner is charged with
the administration of the Radiation
Control for Health and Safety Act of
1968. This Act creates the Committee
and requires the Commissioner to
consult with the Committee before
prescribing standards for radiation
emissions from electronic products.
This Committee provides advice and
consultation to the Commissioner on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
The Committee shall consist of 15
voting members, including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Voting members will
include five members selected from
governmental agencies, including State
and Federal Governments, five members
from the affected industries, and five
members from the general public, of
which at least one shall be a
representative of organized labor. A
quorum shall consist of 10 members, of
which at least 3 shall be from the
general public, 3 from the government
agencies, and 3 from the affected
industries.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/RadiationEmittingProducts/
TechnicalElectronicProduct
RadiationSafetyStandardsCommittee/
default.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
SUPPLEMENTARY INFORMATION:
PO 00000
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please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03239 Filed 2–17–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0115]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff—Class II Special
Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Principle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the collection of
information concerning class II special
controls for an automated blood cell
separator device operating by
centrifugal or filtration separation
principle.
DATES: Submit either electronic or
written comments on the collection of
information by April 19, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 19,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 19, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
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Agencies
[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10107-10108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03269]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment; Notice of Meeting
Pursuant to Public Law 92-463, notice is hereby given that the
Substance Abuse and Mental Health Services Administration's (SAMHSA)
Center for Substance Abuse Treatment (CSAT) National Advisory Council
(NAC) will meet on March 31, 2021, 1:00 p.m.-6:00 p.m. (EDT).
The meeting is open to the public and will include consideration of
minutes from the SAMHSA CSAT NAC meeting of September 22, 2020; an
update on CSAT activities; a discussion with SAMHSA leadership; a
discussion about the use of technology in prevention and treatment of
substance use disorders; and a discussion on rural and frontier
communities.
The meeting will be held via WebEx and telephone only. Interested
persons may present data, information, or views, orally or in writing,
on issues pending before the Council. Oral presentations from the
public will be scheduled at the conclusion of the meeting. Individuals
interested in making oral presentations or written submissions must
notify the contact person on or before March 19, 2021. Up to five
minutes will be allotted for each presentation.
Registration is required to participate. To attend virtually, or to
obtain the call-in number and access code, submit written or brief oral
comments, or request special accommodations for persons with
disabilities, please register on-line at https://snacregister.samhsa.gov/MeetingList.aspx, or communicate with the CSAT
National Advisory Council Designated Federal Officer; (see contact
information below).
Meeting information and a roster of Council members may be obtained
by accessing the SAMHSA Committee
[[Page 10108]]
website at https://www.samhsa.gov/about-us/advisory-councils/csat-national-advisory-council or by contacting the CSAT National Advisory
Council Designated Federal Officer.
Council Name: SAMHSA's Center for Substance Abuse Treatment,
National Advisory Council.
Date/Time/Type: March 31, 2021, 1:00 p.m.-6:00 p.m. EDT, OPEN.
Place: SAMHSA, 5600 Fishers Lane, Rockville, Maryland 20857.
Contact: Tracy Goss, Designated Federal Officer, CSAT National
Advisory Council, 5600 Fishers Lane, Rockville, Maryland 20857 (mail),
Telephone: (240) 276-0759, Email: [email protected].
Dated: February 11, 2021.
Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2021-03269 Filed 2-17-21; 8:45 am]
BILLING CODE 4162-20-P