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Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
July 19, 2022
Jon NakatnOlO
Amazon.com :Services LLC
c/o Amazon Legal I>ept
410 T¢t:ry Ave. N.
Sel\ttle, WA 98lQ9
Re: Revocation ofEUA2l0481
This letter is in response to areguesl from STS Lab H6ldco (a: subsidiary ofAmazon,com
:Services LLC),. received July 11, 2022, that the U.S. Food and.Drug Administration (FDA)
revoke the :BUA forthe Amaz()nMuitM"trrget SMS-Cov:.2 Realmrne RT-PCRTest issued on
August 1.1, 2()21; lifid amendedcmPe:cember
17; -2021, lifidJanuary 26, 2022, FDA @derstands
thereis no viable (non-expired) Amazon.Multi~Targ~ SAR:Sa(;.oV-2 Real-Time RT-PCR Test
remaining in distribution in the United States.
Thea11thorizat:fon of: a de-vice for emergency U$e under section $64 of the Federal Food, Drugi
and Cosmetic Act (theA:ct) (21 U.S:C, 360bbb-3) may, purswm:t to secti:Qn 564(g)(2) of theAGt,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety:. aecaU$e STS Lab.Holdco {a subsidiary of Amazoo..com Services LLC)has notified FDA
that I.here is M viable (JW.tkei\pired) Amaz;on Mulii"Target SAR.S.,CoW2 Real•T:imeRT-PCR
Test remaining in distribu1.ic>n in .lhe United States and requested FDA revok!) tlu, aulhQrizaliQn
of the Amazon Multi-Target SAR.S.,CoV-2 Real-TuneRT;_J>CR Test, FDA has determined that it
i.s appropriate to protect the publi:c health ot safety to revoke th.is amhorization. Accordingly,
FDA hereby revokes EtJA2.104:81. fottbe ArnazonMulti•Target SARS~CoW2 Real-Time RT•
PCR Test; purs~antto sectipn 564(g)(2)(C}ofthe Act As of the di.ife of this letter, the Amazon
Multi-Target SARS-CoV-2 Re~Tme RT.,PCR Test is no longer authorized for emergency use
byf'OA.
Notice of I.his revocation wUl be published in lhe b.e:rJen:.il 8.egtsler, pursuantto section S64.(b)(J)
oftheAcL
Isl
JaGqu:eline A. Q'Shaugbttessy, Ph.D.
Acting Chief Sc.ienti;st
Food and Drug Administration
[FR Doc. 2022–18529 Filed 8–25–22; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0407–30D]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
SUMMARY:
VerDate Sep<11>2014
16:59 Aug 25, 2022
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Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
Comments on the ICR must be
received on or before September 26,
2022.
DATES:
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/
PRAMain. Find this particular
ADDRESSES:
E:\FR\FM\26AUN1.SGM
26AUN1
EN26AU22.009
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
52585
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Submit requests to Sherrette Funn,
Sherrette.Funn@hhs.gov or (202) 264–
0041. When submitting comments or
requesting information, please include
the document identifier OS–0990–0407–
30D and project title for reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
SUPPLEMENTARY INFORMATION:
Title of the Collection: Think Cultural
Health (TCH) website Quality
Improvement Effort.
Type of Collection: Reinstatement
with Change.
OMB No.: 0990–0407.
Abstract: The Office of Minority
Health (OMH), Office of the Secretary
(OS), Department of Health and Human
Services (HHS) is requesting approval
by OMB on a reinstatement with change
to a previously approved data
collection. The Think Cultural Health
(TCH) website is an initiative of the
HHS OMH’s Center for Linguistic and
Cultural Competence in Health Care
(CLCCHC) and is a repository of
resources and tools to promote cultural
and linguistic competency in health and
health care. The TCH website offers a
suite of e-learning programs that afford
health and health care professionals the
ability to earn continuing education
credits through training in cultural and
linguistic competency. The revision to
this information collection request
includes revisions to the online website
registration form to streamline and
change response options for some
elements.
Need and Proposed Use of the
Information: The data will be used to
ensure that the offerings on the TCH
website are relevant, useful, and
appropriate to their target audiences.
The findings from the data collection
will be of interest to HHS OMH in
supporting maintenance and revisions
of the offerings on the TCH website.
Likely Respondents: Likely
respondents are users of the TCH elearning program(s) and/or eresource(s). There are no requirements
for annual, quarterly or monthly
responses. A single respondent
completes the registration process to
access an e-learning program or eresource on the website only one time
and completes a course-specific
evaluation form for each e-learning
program course/unit or e-resource per
completion. A respondent may be
invited to participate in the follow-up
survey, a focus group, or a key
informant interview and will not be
asked to participate in more than one
follow-up activity (i.e., survey, focus
group, or key informant interview).
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Forms
Registration Form ..............................
Course/unit Evaluation Form ............
Follow-Up Survey ..............................
Focus Groups ....................................
Key Informant Interviews ..................
Total ...........................................
Health and
sionals.
Health and
sionals.
Health and
sionals.
Health and
sionals.
Health and
sionals.
Total
burden
hours
1
3/60
473
Health Care Profes-
9,460
1
5/60
788
Health Care Profes-
4,208
1
10/60
701
Health Care Profes-
15
1
120/60
29
Health Care Profes-
13
1
60.60
13
..........................................................
23,156
........................
........................
2,004
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
Average
burden per
response
9,460
[FR Doc. 2022–18415 Filed 8–25–22; 8:45 am]
National Institute on Aging; 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.
16:59 Aug 25, 2022
Number of
responses per
respondents
Health Care Profes-
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
VerDate Sep<11>2014
Number of
respondents
Respondents
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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 Initial Review Group; Career
Development for Clinicians/Health
Professionals Study Section Clinical career
development.
Date: October 3–4, 2022.
Time: 9:30 a.m. to 5:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Maurizio Grimaldi, Ph.D.,
MD, Scientific Review Officer, Scientific
Review Branch, NIA (National Institute on
Aging), Gateway Building, Rm 2W200, 7201
Wisconsin Ave., Bethesda, MD 20892, 301–
496–9374, maurizio.grimaldi@nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nia.nih.gov/, where an agenda and
any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
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File Modified | 2022-08-25 |
File Created | 2022-08-26 |