Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 10107 [2021-03254]
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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
packet. The DMP SAQ will enable CMS
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]
BILLING CODE 4164–01–P
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)
VerDate Sep<11>2014
17:47 Feb 17, 2021
Jkt 253001
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
Frm 00074
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03254]
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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: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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,
[email protected].
SUPPLEMENTARY INFORMATION: 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.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Infant Formula Recall Regulations....... 0910-0188 12/31/2023
State Petitions for Exemption from 0910-0277 12/31/2023
Preemption.............................
Product Jurisdiction and Combination 0910-0523 12/31/2023
Products...............................
Exceptions or Alternatives to Labeling 0910-0614 12/31/2023
Requirements for Products Held by the
Strategic National Stockpile...........
Generic Clearance for the Collection of 0910-0697 12/31/2023
Qualitative Feedback on Food and Drug
Administration Service Delivery........
Registration of Human Drug Compounding 0910-0776 12/31/2023
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]
BILLING CODE 4164-01-P
