Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 73490 [2020-25461]
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
designation annually and assume that
an average of 70 hours is needed to
prepare such a request.
We estimate 205 respondents will
submit 261 requests for fast track
designation requests annually and
assume that an average of 60 hours is
needed to prepare such a request.
Of the requests for fast track
designation made per year, we granted
approximately 224 requests from 392
respondents, and for each of these
granted requests, a premeeting package
was submitted. We therefore assume an
average burden of 100 hours per
respondent for preparing a premeeting
package.
Finally, we estimate 33 respondents
will submit 38 requests for RMAT
designation and assume that an average
of 60 hours is needed to prepare such
a request.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25414 Filed 11–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the Public
Health Service Act and the Federal
Advisory Committee Act, this notice
announces that the Advisory Committee
on Heritable Disorders in Newborns and
Children (ACHDNC or Committee) has
scheduled a public meeting to be held
on Tuesday, December 1, 2020.
Information about the ACHDNC and the
agenda for this meeting can be found on
the ACHDNC website at https://
www.hrsa.gov/advisory-committees/
heritable-disorders/.
DATES: Tuesday, December 1, 2020,
2020, from 10:00 a.m. to 2:45 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required. Please register online at
https://www.cvent.com/d/17qsxn by the
deadline of 12:00 p.m. ET on Monday,
November 30, 2020. Instructions on how
to access the meeting via webcast will
be provided upon registration.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:59 Nov 17, 2020
Jkt 253001
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Room 18W66, Rockville,
Maryland 20857; 301–443–0721; or
ACHDNC@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
the development of newborn screening
activities, technologies, policies,
guidelines, and programs for effectively
reducing morbidity and mortality in
newborns and children having, or at risk
for, heritable disorders. The ACHDNC
reviews and reports regularly on
newborn and childhood screening
practices, recommends improvements in
the national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening,
following adoption by the Secretary, are
evidence-informed preventive health
services provided for in the
comprehensive guidelines supported by
HRSA through the Recommended
Uniform Screening Panel (RUSP)
pursuant to section 2713 of the Public
Health Service Act (42 U.S.C. 300gg–
13). Under this provision, nongrandfathered group health plans and
health insurance issuers offering group
or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
During the meeting, ACHDNC will
hear from experts in the fields of public
health, medicine, heritable disorders,
rare disorders, and newborn screening.
Agenda items include the following:
(1) Presentations on the decision
making criteria and matrix used to
evaluate conditions nominated to the
RUSP;
(2) review of newborn screening
implementation for the following RUSP
conditions: Severe combined
immunodeficiency (SCID), critical
congenital heart disease (CCHD), Pompe
disease, mucopolysaccharidosis type I
(MPS I), X-linked adrenoleukodystrophy
(XALD); and
(3) overview of the Review of
Newborn Screening for Spinal Muscular
Atrophy (SMA) report and vote on
whether to submit this review to the
Secretary.
In July 2018, SMA was added to the
RUSP, and the Secretary requested a
follow-up report that assesses the
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
impact of implementing screening for
SMA. Following the overview of the
Review of Newborn Screening for
Spinal Muscular Atrophy report, the
Committee is expected to vote on
whether to submit this review to the
Secretary or whether further action is
warranted prior to its submission.
The agenda for this meeting does not
include any plans for recommending a
condition for inclusion in the RUSP.
Agenda items are subject to changes as
priorities dictate. Information about the
ACHDNC, including a roster of members
and past meeting summaries, are also
available on the ACHDNC website.
Members of the public also will have
the opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to provide a written statement
or make oral comments to the ACHDNC
must be submitted via the registration
website by Friday, November 27, 2020,
by 10:00 a.m. ET.
Individuals who need special
assistance or another reasonable
accommodation should notify Alaina
Harris at the address and phone number
listed above at least 10 business days
prior to the meeting.
This meeting is being announced less
than 15 days prior to the scheduled
meeting due to an administrative issue
that has now been resolved.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–25461 Filed 11–17–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Treatment and Prevention of
Neuropathic Pain With P2Y14
Antagonists
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive, sublicensable
patent license to Saint Louis University,
(‘‘SLU’’), a non-profit university located
in Missouri, in its rights to the
inventions and patents listed in the
SUMMARY:
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Page 73490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25461]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Committee on Heritable Disorders in
Newborns and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Public Health Service Act and the
Federal Advisory Committee Act, this notice announces that the Advisory
Committee on Heritable Disorders in Newborns and Children (ACHDNC or
Committee) has scheduled a public meeting to be held on Tuesday,
December 1, 2020. Information about the ACHDNC and the agenda for this
meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable-disorders/.
DATES: Tuesday, December 1, 2020, 2020, from 10:00 a.m. to 2:45 p.m.
ET.
ADDRESSES: This meeting will be held via webinar. While this meeting is
open to the public, advance registration is required. Please register
online at https://www.cvent.com/d/17qsxn by the deadline of 12:00 p.m.
ET on Monday, November 30, 2020. Instructions on how to access the
meeting via webcast will be provided upon registration.
FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, Maryland
20857; 301-443-0721; or [email protected].
SUPPLEMENTARY INFORMATION: ACHDNC provides advice and recommendations
to the Secretary of HHS (Secretary) on the development of newborn
screening activities, technologies, policies, guidelines, and programs
for effectively reducing morbidity and mortality in newborns and
children having, or at risk for, heritable disorders. The ACHDNC
reviews and reports regularly on newborn and childhood screening
practices, recommends improvements in the national newborn and
childhood screening programs, and fulfills requirements stated in the
authorizing legislation. In addition, ACHDNC's recommendations
regarding inclusion of additional conditions for screening, following
adoption by the Secretary, are evidence-informed preventive health
services provided for in the comprehensive guidelines supported by HRSA
through the Recommended Uniform Screening Panel (RUSP) pursuant to
section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13).
Under this provision, non-grandfathered group health plans and health
insurance issuers offering group or individual health insurance are
required to provide insurance coverage without cost-sharing (a co-
payment, co-insurance, or deductible) for preventive services for plan
years (i.e., policy years) beginning on or after the date that is one
year from the Secretary's adoption of the condition for screening.
During the meeting, ACHDNC will hear from experts in the fields of
public health, medicine, heritable disorders, rare disorders, and
newborn screening. Agenda items include the following:
(1) Presentations on the decision making criteria and matrix used
to evaluate conditions nominated to the RUSP;
(2) review of newborn screening implementation for the following
RUSP conditions: Severe combined immunodeficiency (SCID), critical
congenital heart disease (CCHD), Pompe disease, mucopolysaccharidosis
type I (MPS I), X-linked adrenoleukodystrophy (XALD); and
(3) overview of the Review of Newborn Screening for Spinal Muscular
Atrophy (SMA) report and vote on whether to submit this review to the
Secretary.
In July 2018, SMA was added to the RUSP, and the Secretary
requested a follow-up report that assesses the impact of implementing
screening for SMA. Following the overview of the Review of Newborn
Screening for Spinal Muscular Atrophy report, the Committee is expected
to vote on whether to submit this review to the Secretary or whether
further action is warranted prior to its submission.
The agenda for this meeting does not include any plans for
recommending a condition for inclusion in the RUSP. Agenda items are
subject to changes as priorities dictate. Information about the ACHDNC,
including a roster of members and past meeting summaries, are also
available on the ACHDNC website.
Members of the public also will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting. Oral comments will be honored in the order
they are requested and may be limited as time allows. Requests to
provide a written statement or make oral comments to the ACHDNC must be
submitted via the registration website by Friday, November 27, 2020, by
10:00 a.m. ET.
Individuals who need special assistance or another reasonable
accommodation should notify Alaina Harris at the address and phone
number listed above at least 10 business days prior to the meeting.
This meeting is being announced less than 15 days prior to the
scheduled meeting due to an administrative issue that has now been
resolved.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-25461 Filed 11-17-20; 8:45 am]
BILLING CODE 4165-15-P
