National Committee on Vital and Health Statistics: Meeting, 67746-67747 [2020-23668]
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Federal Register / Vol. 85, No. 207 / Monday, October 26, 2020 / Notices
II. FDA Determination of Alignment of
Third-Party Food Safety Standards
Voluntary Pilot Program
A. Scope and Selection Attributes
FDA is seeking requests for
participation from members of the
public, including owners of third-party
human food safety standards, who are
interested in participating in a voluntary
pilot program to determine whether
third-party food safety standards align
with food safety requirements in the
PCHF and the Produce Safety
regulations. Upon being selected to
participate in the program, participants
will submit their standards for
assessment. FDA plans to select and
assess up to five private third-party
human food safety standards for
alignment with food safety requirements
in the PCHF or the Produce Safety
regulation. Participants in the pilot
program will be asked to provide FDA
with technical feedback on the pilot.
The Agency will use its discretion in
choosing participants for assessment
based on (in no particular order):
(1) The order the requests for
participation are received;
(2) the desired diversity of third-party
human food safety standards for
assessment in the pilot (e.g., PCHF,
Produce Safety); and
(3) the Agency’s determination of
available resources to conduct the
assessment given the level of effort and
other priorities.
FDA reserves the right to request
additional information or clarification
from participants in the pilot and to
rescind participation if the additional
information or clarification is not
promptly and accurately provided.
B. Duration
The pilot will run for 1 year from the
date of publication of this notice and
will conclude on October 26, 2021. FDA
reserves the right to extend the pilot for
more time as needed. To assure we have
adequate time to assess the standards
during the pilot period, we are asking
members of the public, including
owners of third-party human food safety
standards, to submit their request to
participate in the pilot program by
November 25, 2020.
C. Submission of Requests To
Participate
Members of the public, including
owners of third-party human food safety
standards, that are interested in
participating should submit a written
request to participate to Franciel Ikeji
(see FOR FURTHER INFORMATION CONTACT).
Electronic requests should be submitted
to StandardsAlignmentPilot@
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fda.hhs.gov. We strongly encourage
interested persons to electronically
submit their requests to participate.
Written and electronic requests to
participate in the pilot program should
be submitted by November 25, 2020.
The request to participate should
include the following information:
Company and contact name; contact
phone number; and contact email
address. Additionally, although not
required for consideration, FDA is
particularly interested in whether you
are the owner of a third-party food
safety standard, and the type of food
safety standard you have developed
(e.g., produce safety, human processed
food). For a limited number of
applicants that FDA identifies as
possible candidates for participation in
the pilot, FDA may ask you to submit
a completed FDA Food Safety Audit
Comparison Template https://
www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm602286.htm. If the pilot participant
chooses to submit an alternative
comparison tool, the format should
enable FDA to easily compare the thirdparty food safety standard to the
relevant FDA regulations (i.e., placing
the relevant requirements of FDA’s
regulations in numerical order to the left
of any third-party food safety
standards). FDA may also ask pilot
participants for additional information
on submitted food safety standards.
D. Assessment and Alignment of
Program Standards
The pilot program will be conducted
from October 26, 2020 to October 26,
2021 and may be extended as needed.
Each person that submits a request to
participate will be notified that FDA has
received the request. This notification
only acknowledges that FDA has
received the request and does not
guarantee that FDA will accept you for
participation in the pilot. By the
conclusion of the pilot, participants will
be notified as to whether FDA
determined the food safety standard to
be in alignment or not in alignment with
the relevant FDA regulation.
FDA will publish information on its
website regarding the third-party
standards that FDA determines to be in
alignment with FDA regulations.
E. Evaluation of Pilot Program
FDA intends to evaluate the pilot
program on several factors, including,
but not limited to, the resources
required to review and assess thirdparty standards for alignment with
relevant FDA regulations, the ability of
pilot participants to provide adequate
information to enable FDA to make a
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determination of alignment, and
whether FDA Audit Comparison
Templates are a helpful tool in making
alignment determinations. After FDA
evaluates the pilot program, the Agency
will utilize the information to evaluate
the resources and tools required to
conduct alignment reviews.
Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS), Full
Committee Meeting.
Dates and Times: Wednesday,
November 18, 2020: 10:00 a.m.–5:30
p.m. EST.
Thursday, November 19, 2020: 11:30
a.m.–4:00 p.m. EST.
Place: Virtual.
Status: Open.
Purpose: At the November 18–19,
2020, meeting, the Committee will
receive briefings from HHS officials,
hold discussions on several health data
policy topics and discuss its work plan
for the upcoming 12-month period. The
Committee will welcome four new
members.
The Subcommittee on Standards will
provide an update on follow up work
from its hearing held in August 2020 to
solicit information about the costs and
benefits of a new operating rule for
connectivity and two operating rules for
the prior authorization transaction
proposed by the Council for Affordable
Quality Healthcare (CAQH), Committee
on Operating Rules for Information
Exchange (CORE). The Committee will
also consider recommendations
anticipated from the Office of the
National Coordinator for Health
Information Technology’s (ONC) Health
Information Technology Advisory
Committee (HITAC), Task Force on
Intersection of Clinical and
Administrative Data (ICAD), on which
four NCVHS members have
participated. The Committee will
consider next steps for a project to
identify and recommend a path toward
convergence of administrative and
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Federal Register / Vol. 85, No. 207 / Monday, October 26, 2020 / Notices
clinical data in light of the Task Force
recommendations. The Committee has
invited a representative of the new
Office of Burden Reduction and Health
Informatics, Centers for Medicare and
Medicaid Services, to provide an update
on the work of the Office and the
potential intersection with the NCVHS
work plan.
The Subcommittee on Privacy,
Confidentiality, and Security will
provide an update on the September 14,
2020, hearing that focused on data
collection and use during a public
health emergency and identify next
steps for development of guidelines for
methods and approaches to collect, use,
protect, and share data responsibly
during a pandemic or long-term
nationwide public health emergency.
Members will consider major themes
for the NCVHS 14th Report to Congress,
which is planned for release in the first
half of 2021. Members will consider and
discuss priorities for Committee focus
and revise the Committee work plan
based on the two days of meeting
proceedings.
A public comment period will be
offered on both days. Meeting times and
topics are subject to change. Please refer
to the agenda posted at the NCVHS
website for any updates.
Contact Person for More Information:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, or via electronic mail to vgh4@
cdc.gov; or by telephone (301) 458–
4715. Summaries of meetings and a
roster of Committee members are
available on the home page of the
NCVHS website, https://ncvhs.hhs.gov/,
where further information including an
agenda and instructions to access the
broadcast of the meeting will also be
posted.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Sharon Arnold,
Associate Deputy Assistant Secretary for
Planning and Evaluation, Science and Data
Policy, Office of the Assistant Secretary for
Planning and Evaluation.
[FR Doc. 2020–23668 Filed 10–23–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Special Emphasis
Panel, December 3, 2020, 9:00 a.m. to
5:30 p.m. This notice was published in
the Federal Register on September 29,
2020, 85 FR 189, Page 61020.
This notice is being amended to
change the date and time to December
17, 2020 from 10:00 a.m. to 5:30 p.m.
The meeting is closed to the public.
Dated: October 20, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–23584 Filed 10–23–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Ocular
Surface, Cornea, Anterior Segment Glaucoma
and Refractive Error.
Date: November 17, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Julius Cinque, MS,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, (301) 435–
1252, cinquej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Metabolism.
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Date: November 20, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Hui Chen, MD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6164, Bethesda, MD 20892,
(301) 435–1044, chenhui@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Disease Prevention and
Management, Risk Reduction and Health
Behavior Change.
Date: November 23, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Michael J McQuestion,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114
MSC 7808, Bethesda, MD 20892, (301) 480–
1276, mike.mcquestion@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–19–
367: Maximizing Investigators’ Research
Award (R35—Clinical Trial Optional).
Date: November 23–24, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, (301) 435–
1022, balasundaramd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–20–
131: Mammalian Models for Translational
Research.
Date: November 23, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Malaya Chatterjee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health,6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, (301) 806–
2515, chatterm@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
HIV Molecular Virology, Cell Biology, and
Drug Development Study Section.
Date: November 23–24, 2020.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
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]]>Agencies
[Federal Register Volume 85, Number 207 (Monday, October 26, 2020)]
[Notices]
[Pages 67746-67747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23668]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Committee on Vital and Health Statistics: Meeting
Pursuant to the Federal Advisory Committee Act, the Department of
Health and Human Services (HHS) announces the following advisory
committee meeting.
Name: National Committee on Vital and Health Statistics (NCVHS),
Full Committee Meeting.
Dates and Times: Wednesday, November 18, 2020: 10:00 a.m.-5:30 p.m.
EST.
Thursday, November 19, 2020: 11:30 a.m.-4:00 p.m. EST.
Place: Virtual.
Status: Open.
Purpose: At the November 18-19, 2020, meeting, the Committee will
receive briefings from HHS officials, hold discussions on several
health data policy topics and discuss its work plan for the upcoming
12-month period. The Committee will welcome four new members.
The Subcommittee on Standards will provide an update on follow up
work from its hearing held in August 2020 to solicit information about
the costs and benefits of a new operating rule for connectivity and two
operating rules for the prior authorization transaction proposed by the
Council for Affordable Quality Healthcare (CAQH), Committee on
Operating Rules for Information Exchange (CORE). The Committee will
also consider recommendations anticipated from the Office of the
National Coordinator for Health Information Technology's (ONC) Health
Information Technology Advisory Committee (HITAC), Task Force on
Intersection of Clinical and Administrative Data (ICAD), on which four
NCVHS members have participated. The Committee will consider next steps
for a project to identify and recommend a path toward convergence of
administrative and
[[Page 67747]]
clinical data in light of the Task Force recommendations. The Committee
has invited a representative of the new Office of Burden Reduction and
Health Informatics, Centers for Medicare and Medicaid Services, to
provide an update on the work of the Office and the potential
intersection with the NCVHS work plan.
The Subcommittee on Privacy, Confidentiality, and Security will
provide an update on the September 14, 2020, hearing that focused on
data collection and use during a public health emergency and identify
next steps for development of guidelines for methods and approaches to
collect, use, protect, and share data responsibly during a pandemic or
long-term nationwide public health emergency.
Members will consider major themes for the NCVHS 14th Report to
Congress, which is planned for release in the first half of 2021.
Members will consider and discuss priorities for Committee focus and
revise the Committee work plan based on the two days of meeting
proceedings.
A public comment period will be offered on both days. Meeting times
and topics are subject to change. Please refer to the agenda posted at
the NCVHS website for any updates.
Contact Person for More Information: Substantive program
information may be obtained from Rebecca Hines, MHS, Executive
Secretary, NCVHS, National Center for Health Statistics, Centers for
Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland
20782, or via electronic mail to [email protected]; or by telephone (301)
458-4715. Summaries of meetings and a roster of Committee members are
available on the home page of the NCVHS website, https://ncvhs.hhs.gov/
, where further information including an agenda and instructions to
access the broadcast of the meeting will also be posted.
Should you require reasonable accommodation, please contact the CDC
Office of Equal Employment Opportunity on (770) 488-3210 as soon as
possible.
Sharon Arnold,
Associate Deputy Assistant Secretary for Planning and Evaluation,
Science and Data Policy, Office of the Assistant Secretary for Planning
and Evaluation.
[FR Doc. 2020-23668 Filed 10-23-20; 8:45 am]
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