Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Amendment of Notice, 58800-58801 [2022-20985]
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58800
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Human Trafficking Youth
Prevention Education Demonstration
Grant Program Process Evaluation
(New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), in
collaboration with the Office on
Trafficking in Persons (OTIP), is
proposing a new data collection activity
for the Human Trafficking Youth
Prevention Education (HTYPE)
Demonstration Grant Program Process
Evaluation. The process evaluation will
explore whether the program is being
implemented as intended, describe the
successes and barriers that have been
encountered, and highlight the changes
that may be needed to support program
implementation.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
SUMMARY:
Reduction Act (PRA) of 1995, ACF is
soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The goal of the HTYPE
Demonstration Grant Program is to
support local educational agencies
(LEA) to partner with a nonprofit or
Non-Governmental Organization to
build the capacity of schools to provide
skills-based human trafficking
prevention education for educators,
other staff, and students, and to
establish a Human Trafficking School
Safety Protocol (HTSSP) that addresses
the safety, security, and well-being of
staff and students. Eight HTYPE
Demonstration Program project grants
were awarded in September 2020, with
a period of performance of 36 months.
The purpose of the proposed
information collection is to investigate
and document how HTYPE projects
approach and accomplish the goals of
the HTYPE Demonstration Grant
Program, inform ACF’s efforts to
support human trafficking prevention
education in schools, and inform future
evaluation efforts.
The proposed information collection
activities include:
(1) One-time, semi-structured
interviews or focus groups with trained
LEA staff and implementers at select
schools from each grant recipient site.
Interviews/focus groups will include
questions focused on implementation
models, participant and implementer
engagement, and implementation
facilitators and barriers.
(2) One-time, semi-structured
interviews with school staff related to
the process and implementation of the
HTSSP at select schools from each grant
recipient site.
(3) One-time web survey with school
administrators, which will include
questions focused on school context and
engagement, training mandates,
implementation models, and
implementation facilitators and barriers.
(4) One-time web survey with school
staff tasked with implementing the
HTYPE curriculum, which will include
questions focused on educator training,
student curriculum implementation
models and quality, participant and
implementer engagement, and
implementation facilitators and barriers.
Respondents: LEA staff who have
been involved in the HTYPE
demonstration programs, including
school leadership/administrators,
curriculum implementers, and staff who
have received human trafficking
training.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
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HTYPE
HTYPE
HTYPE
HTYPE
Training Implementation Interview/Focus Group Guide .....................
HTSSP Walk-Through Guide .............................................................
School Administrator Survey ..............................................................
Implementer Survey ............................................................................
Estimated Total Annual Burden
Hours: 745.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
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Number of
responses per
respondent
(total over
request
period)
192
24
321
1437
1
1
1
1
Average
burden per
response
(in hours)
Total/annual
burden
(in hours)
1.5
.75
.25
.25
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: Section 105(d)(2) of the
Trafficking Victims Protection Act (TVPA) of
2000 (Pub. L. 106–386) 105 [22 U.S.C. 7103]
[Docket No. FDA–2022–N–1914]
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–20939 Filed 9–27–22; 8:45 am]
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Food and Drug Administration
Clinical Chemistry and Clinical
Toxicology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
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Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
ACTION:
Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is announcing a
correction to the notice of meeting of the
Clinical Chemistry and Clinical
Toxicology Devices Panel of the Medical
Devices Advisory Committee. This
meeting was announced in the Federal
Register of September 2, 2022. The
correction is being made to reflect a
change to the sponsor’s name. There are
no other changes.
SUMMARY:
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver Spring,
MD 20993–0002, 301–796–6313,
James.Swink@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
In the
Federal Register of September 2, 2022
(87 FR 54221), FDA announced that a
meeting of the Clinical Chemistry and
Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee
would be held on October 20, 2022. On
page 54222, in the second column, in
the Agenda portion of the document,
the second sentence ‘‘On October 20,
2022, the committee will discuss, make
recommendations, and vote on clinical
information related to the De Novo
request for the AvertD Test sponsored
by SolvD, Inc.’’ is changed to read as
follows: ‘‘On October 20, 2022, the
committee will discuss, make
recommendations, and vote on clinical
information related to the De Novo
request for the AvertD Test sponsored
by SOLVD Health.’’
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: September 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20985 Filed 9–27–22; 8:45 am]
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[Docket No. FDA–2022–N–2186]
Request for Nominations on the
Tobacco Products Scientific Advisory
Committee—Small Business Pool
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any small business
tobacco manufacturing industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Tobacco
Products Scientific Advisory Committee
for the Center for Tobacco Products
notify FDA in writing. FDA is also
requesting nominations for nonvoting
industry representatives to be included
in a pool of individuals to represent the
interests of the small business tobacco
manufacturing industry on the Tobacco
Products Scientific Advisory
Committee. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. This position
may be filled on a rotating, sequential
basis by representatives of different
small business tobacco manufacturers
based on areas of expertise relevant to
the topics being considered by the
Advisory Committee. Nominations will
be accepted for current vacancies
effective with this notice.
DATES: Any small business tobacco
manufacturing industry organization
interested in participating in the
selection of appropriate nonvoting
members to represent industry interests
must send a letter stating that interest to
the FDA by October 28, 2022 (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to *FDA by
October 28, 2022.
ADDRESSES: All statements of interest
from small business tobacco
manufacturing industry organizations
interested in participating in the
selection process of nonvoting industry
representative nominations should be
sent to Serina Hunter-Thomas (see FOR
FURTHER INFORMATION CONTACT). All
nominations for nonvoting industry
representatives may be submitted
electronically by accessing the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
PO 00000
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58801
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products,
Food and Drug Administration, Center
for Tobacco Products Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002,1–877–287–1373 (choose
Option 5), or by email: TPSAC@
fda.hhs.gov.
The
Agency intends to add nonvoting
industry representative(s) to the
following advisory committee:
SUPPLEMENTARY INFORMATION:
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of FDA (the
Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
to tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
The Committee includes three
nonvoting members who represent
industry interests. These members
include one representative of the
interests of the tobacco manufacturing
industry, one representative of the
interests of tobacco growers, and one
representative of the interests of the
small business tobacco manufacturing
industry, which may be filled on a
rotating, sequential basis by
representatives of different small
business tobacco manufacturers based
on areas of expertise relevant to the
topics being considered by the Advisory
Committee.
With this notice, nominations are
sought for the following positions: a
pool of individuals, with varying areas
of expertise, to represent the interests of
the small business tobacco
manufacturing industry on a rotating,
sequential basis.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
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]]>Agencies
[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58800-58801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1914]
Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
[[Page 58801]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
correction to the notice of meeting of the Clinical Chemistry and
Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee. This meeting was announced in the Federal Register of
September 2, 2022. The correction is being made to reflect a change to
the sponsor's name. There are no other changes.
FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002, 301-796-6313,
[email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area). Please call the
Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 2, 2022
(87 FR 54221), FDA announced that a meeting of the Clinical Chemistry
and Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee would be held on October 20, 2022. On page 54222, in the
second column, in the Agenda portion of the document, the second
sentence ``On October 20, 2022, the committee will discuss, make
recommendations, and vote on clinical information related to the De
Novo request for the AvertD Test sponsored by SolvD, Inc.'' is changed
to read as follows: ``On October 20, 2022, the committee will discuss,
make recommendations, and vote on clinical information related to the
De Novo request for the AvertD Test sponsored by SOLVD Health.''
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: September 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20985 Filed 9-27-22; 8:45 am]
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