Health Information Technology Advisory Committee 2020 Schedule-Revised; Meeting, 38905-38906 [2020-13978]
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Federal Register / Vol. 85, No. 125 / Monday, June 29, 2020 / Notices
normal metabolizer) could be given for
those patients.
Based on prescription dispensing data
obtained from a proprietary drug
utilization database available to FDA,
the Agency understands that the
number of patients ages 0 to 11 who
were dispensed codeine-containing
analgesic products decreased from an
estimated 735,000 patients in 2013 to
230,000 patients in 2017. Following the
addition of the contraindication of
codeine-containing drug products in
children under 12 years of age to the
codeine product labeling in August
2017, FDA has seen the prescription use
of codeine decline further to 84,000
patients ages 0 to less than 12 years of
age in 2018.4
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II. Additional Issues for Consideration
and Request for Information
FDA is soliciting information and
comment from stakeholders regarding
the issues described in this document.
In addition to any other aspects of these
issues that stakeholders may care to
comment upon, FDA is interested in
answers to the following questions in
particular:
Topic 1: Pain Management in Children
Under 12 Years of Age (for Prescribers
and Other Stakeholders, as
Appropriate)
1. What factors do you consider in
choosing to prescribe an opioid
analgesic for children under 12 years of
age who require treatment for recurrent
episodes of acute pain (e.g., severity of
pain, lack of response to other
analgesics, or the specific disease, such
as children with sickle cell diseaserelated pain crises)?
2. Which pediatric populations, other
than children with sickle cell disease,
typically use an opioid analgesic for
recurrent episodes of acute pain?
3. What role, if any, do you see for
codeine/acetaminophen combination
drug products in the treatment of
children under 12 years of age with
recurrent episodes of acute pain?
4. What is your institution/
department/clinical practice’s
recommended approach (or specific
formulary options) for selecting an
opioid analgesic for a child under 12
years of age? Was your institution/
department/clinical practice’s current
approach modified following FDA’s
August 2017 codeine labeling revision
that contraindicated codeine-containing
drug products in children under 12
years of age? If there is not a
recommended approach, what opioid
4 Source:
IQVIA Total Patient TrackerTM, 2013–
2018. Data extracted May 2018 and June 2019.
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analgesics are typically prescribed in
your practice to patients under 12 years
of age?
5. In your view/experience, is the
contraindication for use of codeine/
acetaminophen combination drug
products in children under 12 years of
age hampering optimal patient care?
6. What are the issues you have faced
regarding urgent access to opioid
analgesics (e.g., after hours, on
weekends, and holidays) for a child
under 12 years of age with recurrent
episodes of acute pain requiring an
opioid analgesic?
a. For clinicians: If you have had to
face these issues, how do they impact
prescribing decisions? For example,
would you consider giving a hard copy
prescription for a small amount of
opioid analgesic to be used in urgent or
after-hours situations so the patient can
avoid making a visit for urgent/
emergency care?
b. For caregivers/patient advocates:
How have you handled these issues?
38905
2. What is your practice regarding eprescribing of Schedule II opioids? Are
there any limitations in your institution/
department/clinical practice for eprescribing of Schedule II opioids?
3. Would you e-prescribe a Schedule
II opioid based on a telephone
discussion with a child’s caregiver?
Would you e-prescribe any opioid
(including those in Schedule III and
Schedule IV) based on a telephone
discussion with a child’s caregiver?
Describe why or why not.
4. If you do not have e-prescribing
available, how does that impact your
ability to prescribe Schedule II opioids
for children under 12 years of age,
particularly with recurrent acute pain
episodes?
Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13974 Filed 6–26–20; 8:45 am]
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Topic 2: CYP2D6 Genotyping Tests (for
Prescribers and Technical Experts)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. Would amending the
contraindication to provide for CYP2D6
genotyping for children under 12 years
of age prior to prescription of codeinecontaining drug products change your
clinical practice?
2. Have you utilized a CYP2D6
genotyping test when determining
which opioid analgesic to select for a
child under 12 years of age who has
recurrent acute pain severe enough to
warrant treatment with an opioid
analgesic? Describe why or why not.
3. Describe your experience with
interpreting CYP2D6 genotyping test
results and using those results to make
drug prescribing decisions.
4. For a CYP2D6 genotyping test to
appropriately identify patients who can
safely receive a codeine-containing drug
product, what is the minimum
genotyping accuracy and minimum
acceptable coverage of the currently
known genotypes that typically result in
a poor metabolizer or ultra-rapid
metabolizer phenotype?
5. Regarding detection of ultra-rapid
metabolizers, what is the type of test
output that would be needed for copy
number? Is a result of ‘‘duplication
present’’ (i.e., more than one copy)
sufficient, or is specific quantitation of
the number of copies needed?
Health Information Technology
Advisory Committee 2020 Schedule—
Revised; Meeting
Topic 3: E-Prescribing Availability (for
Prescribers)
1. Is e-prescribing available in your
institution/department/clinical
practice?
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Office of the National
Coordinator for Health Information
Technology (ONC), HHS.
ACTION: Notice of meeting.
AGENCY:
The Health Information
Technology Advisory Committee
(HITAC) was established in accordance
with section 4003(e) of the 21st Century
Cures Act and the Federal Advisory
Committee Act. The HITAC, among
other things, identifies priorities for
standards adoption and makes
recommendations to the National
Coordinator for Health Information
Technology (National Coordinator). The
HITAC will hold public meetings
throughout 2020. See list of public
meetings below.
FOR FURTHER INFORMATION CONTACT:
Lauren Richie, Designated Federal
Officer, at Lauren.Richie@hhs.gov, (202)
205–7674.
SUPPLEMENTARY INFORMATION: Section
4003(e) of the 21st Century Cures Act
(Pub. L. 114–255) establishes the Health
Information Technology Advisory
Committee (referred to as the ‘‘HITAC’’).
The HITAC will be governed by the
provisions of the Federal Advisory
Committee Act (FACA) (Pub. L. 92–
463), as amended, (5 U.S.C. App.),
which sets forth standards for the
formation and use of federal advisory
committees.
SUMMARY:
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38906
Federal Register / Vol. 85, No. 125 / Monday, June 29, 2020 / Notices
Composition
The HITAC is comprised of at least 25
members, of which:
• No fewer than 2 members are
advocates for patients or consumers of
health information technology;
• 3 members are appointed by the
HHS Secretary
Æ 1 of whom shall be appointed to
represent the Department of Health and
Human Services and
Æ 1 of whom shall be a public health
official;
• 2 members are appointed by the
majority leader of the Senate;
• 2 members are appointed by the
minority leader of the Senate;
• 2 members are appointed by the
Speaker of the House of Representatives;
• 2 members are appointed by the
minority leader of the House of
Representatives; and
• Other members are appointed by
the Comptroller General of the United
States.
Members will serve for one-, two-, or
three-year terms. All members may be
reappointed for a subsequent three-year
term. Each member is limited to two
three-year terms, not to exceed six years
of service. After establishment, members
shall be appointed for a three-year term.
Members serve without pay, but will be
provided per-diem and travel costs for
committee services.
Recommendations
The HITAC recommendations to the
National Coordinator are publicly
available at https://www.healthit.gov/
topic/federal-advisory-committees/
recommendations-national-coordinatorhealth-it.
jbell on DSKJLSW7X2PROD with NOTICES
Public Meetings
The revised schedule of meetings to
be held in 2020 is as follows:
• January 15, 2020 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time at the Washington Plaza
Hotel, 10 Thomas Circle NW,
Washington, DC 20005
• February 19, 2020 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
• March 18, 2020 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
• March 26, 2020 from approximately
10:30 a.m. to 1:30 p.m./Eastern Time
(virtual meeting)
• April 15, 2020 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
• May 20, 2020 from approximately
9:30 a .m. to 2:30 p.m./Eastern Time
(virtual meeting)
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•(June 17, 2020 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
• September 9, 2020 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
• October 21, 2020 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
• November 10, 2020 from
approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
All meetings are open to the public.
Additional meetings may be scheduled
as needed. For web conference
instructions and the most up-to-date
information, please visit the HITAC
calendar on the ONC website,https://
www.healthit.gov/topic/federaladvisory-committees/hitac-calendar.
Contact Person for Meetings: Lauren
Richie, lauren.richie@hhs.gov . A notice
in the Federal Register about last
minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Please email Lauren
Richie for the most current information
about meetings.
Agenda: As outlined in the 21st
Century Cures Act, the HITAC will
develop and submit recommendations
to the National Coordinator on the
topics of interoperability, privacy and
security, and patient access. In addition,
the committee will also address any
administrative matters and hear
periodic reports from ONC. ONC
intends to make background material
available to the public no later than 24
hours prior to the meeting start time. If
ONC is unable to post the background
material on its website prior to the
meeting, the material will be made
publicly available at the location of the
advisory committee meeting, and the
background material will be posted on
ONC’s website after the meeting, at
https://www.healthit.gov/hitac.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person prior to the meeting date. An
oral public comment period will be
scheduled at each meeting. Time
allotted for each presentation will be
limited to three minutes. If the number
of speakers requesting to comment is
greater than can be reasonably
accommodated during the scheduled
public comment period, ONC will take
written comments after the meeting.
Persons attending ONC’s HITAC
meetings are advised that the agency is
not responsible for providing wireless
access or access to electrical outlets.
PO 00000
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ONC welcomes the attendance of the
public at its HITAC meetings. Seating is
limited at the location, and ONC will
make every effort to accommodate
persons with physical disabilities or
special needs. If you require special
accommodations due to a disability,
please contact Lauren Richie at least
seven (7) days in advance of the
meeting.
Notice of these meetings are given
under the Federal Advisory Committee
Act (Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: June 23, 2020.
Cassandra Hadley,
Office of Policy, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. 2020–13978 Filed 6–26–20; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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.
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NHP MHC and KIR Allele
Discovery and Typing Technology
Development.
Date: July 21, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Tara Capece, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G41 Rockville, MD
20852 301–761–7854 capecet2@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
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]]>Agencies
[Federal Register Volume 85, Number 125 (Monday, June 29, 2020)]
[Notices]
[Pages 38905-38906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Information Technology Advisory Committee 2020 Schedule--
Revised; Meeting
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Health Information Technology Advisory Committee (HITAC)
was established in accordance with section 4003(e) of the 21st Century
Cures Act and the Federal Advisory Committee Act. The HITAC, among
other things, identifies priorities for standards adoption and makes
recommendations to the National Coordinator for Health Information
Technology (National Coordinator). The HITAC will hold public meetings
throughout 2020. See list of public meetings below.
FOR FURTHER INFORMATION CONTACT: Lauren Richie, Designated Federal
Officer, at Lauren.Richi[email protected], (202) 205-7674.
SUPPLEMENTARY INFORMATION: Section 4003(e) of the 21st Century Cures
Act (Pub. L. 114-255) establishes the Health Information Technology
Advisory Committee (referred to as the ``HITAC''). The HITAC will be
governed by the provisions of the Federal Advisory Committee Act (FACA)
(Pub. L. 92-463), as amended, (5 U.S.C. App.), which sets forth
standards for the formation and use of federal advisory committees.
[[Page 38906]]
Composition
The HITAC is comprised of at least 25 members, of which:
No fewer than 2 members are advocates for patients or
consumers of health information technology;
3 members are appointed by the HHS Secretary
[cir] 1 of whom shall be appointed to represent the Department of
Health and Human Services and
[cir] 1 of whom shall be a public health official;
2 members are appointed by the majority leader of the
Senate;
2 members are appointed by the minority leader of the
Senate;
2 members are appointed by the Speaker of the House of
Representatives;
2 members are appointed by the minority leader of the
House of Representatives; and
Other members are appointed by the Comptroller General of
the United States.
Members will serve for one-, two-, or three-year terms. All members
may be reappointed for a subsequent three-year term. Each member is
limited to two three-year terms, not to exceed six years of service.
After establishment, members shall be appointed for a three-year term.
Members serve without pay, but will be provided per-diem and travel
costs for committee services.
Recommendations
The HITAC recommendations to the National Coordinator are publicly
available at https://www.healthit.gov/topic/federal-advisory-committees/recommendations-national-coordinator-health-it.
Public Meetings
The revised schedule of meetings to be held in 2020 is as follows:
January 15, 2020 from approximately 9:30 a.m. to 2:30
p.m./Eastern Time at the Washington Plaza Hotel, 10 Thomas Circle NW,
Washington, DC 20005
February 19, 2020 from approximately 9:30 a.m. to 2:30
p.m./Eastern Time (virtual meeting)
March 18, 2020 from approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
March 26, 2020 from approximately 10:30 a.m. to 1:30 p.m./
Eastern Time (virtual meeting)
April 15, 2020 from approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
May 20, 2020 from approximately 9:30 a .m. to 2:30 p.m./
Eastern Time (virtual meeting)
(June 17, 2020 from approximately 9:30 a.m. to 2:30 p.m./
Eastern Time (virtual meeting)
September 9, 2020 from approximately 9:30 a.m. to 2:30
p.m./Eastern Time (virtual meeting)
October 21, 2020 from approximately 9:30 a.m. to 2:30
p.m./Eastern Time (virtual meeting)
November 10, 2020 from approximately 9:30 a.m. to 2:30
p.m./Eastern Time (virtual meeting)
All meetings are open to the public. Additional meetings may be
scheduled as needed. For web conference instructions and the most up-
to-date information, please visit the HITAC calendar on the ONC
website,https://www.healthit.gov/topic/federal-advisory-committees/hitac-calendar.
Contact Person for Meetings: Lauren Richie, [email protected] .
A notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Please email
Lauren Richie for the most current information about meetings.
Agenda: As outlined in the 21st Century Cures Act, the HITAC will
develop and submit recommendations to the National Coordinator on the
topics of interoperability, privacy and security, and patient access.
In addition, the committee will also address any administrative matters
and hear periodic reports from ONC. ONC intends to make background
material available to the public no later than 24 hours prior to the
meeting start time. If ONC is unable to post the background material on
its website prior to the meeting, the material will be made publicly
available at the location of the advisory committee meeting, and the
background material will be posted on ONC's website after the meeting,
at https://www.healthit.gov/hitac.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person prior to the
meeting date. An oral public comment period will be scheduled at each
meeting. Time allotted for each presentation will be limited to three
minutes. If the number of speakers requesting to comment is greater
than can be reasonably accommodated during the scheduled public comment
period, ONC will take written comments after the meeting.
Persons attending ONC's HITAC meetings are advised that the agency
is not responsible for providing wireless access or access to
electrical outlets.
ONC welcomes the attendance of the public at its HITAC meetings.
Seating is limited at the location, and ONC will make every effort to
accommodate persons with physical disabilities or special needs. If you
require special accommodations due to a disability, please contact
Lauren Richie at least seven (7) days in advance of the meeting.
Notice of these meetings are given under the Federal Advisory
Committee Act (Pub. L. 92-463, 5 U.S.C., App. 2).
Dated: June 23, 2020.
Cassandra Hadley,
Office of Policy, Office of the National Coordinator for Health
Information Technology.
[FR Doc. 2020-13978 Filed 6-26-20; 8:45 am]
BILLING CODE 4150-45-P
