Proposed Establishment of the Advisory Committee on Heritable Disorders in Newborns and Children, 67357-67358 [2020-23363]
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Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
II. Project Participation
CDER is seeking a maximum of five
participants in this pilot. The Center
will use its discretion in choosing
participants based on the completeness
of the submission per the guidelines
below. CDER requests participants to
submit a nonclinical study package
containing the materials:
• SEND–DART v1.1 datasets;
• final related study report containing
individual animal data and summary
tables 6 (PDF Format);
• nonclinical Study Data Reviewers
Guide; 7
• define.xml (v2.0); 8 and
• sample standardization study
protocol.
CDER will prioritize nonclinical
packages that contain Embryo-Fetal
Development (EFD) Toxicity studies
(using pre-bred females only) that
contain data that is consistent with
SEND–DART v1.1. Therefore, the
studies that meet as many of the
following use cases as possible will be
the most sought out as participants in
this pilot:
• Small animals (rodents, rabbits),
pre-bred females, treatment period
during implanted embryo’s major
organogenesis period;
• material toxicity endpoints
(minimum CL, BW, FW, DS);
• caesarean section endpoints in PY,
IC, FM, FX (pregnancy, Corpora Lutea,
implantations, resorptions, fetal
viability, fetal sex and body weights,
fetal morphology);
• toxicokinetic females to illustrate in
Trial Design and pregnancy results (PC,
PP domains optional);
• LB domain optional since not
routine in EFD Toxicity study;
• MA optional (if gross observations
scheduled, may not be in preliminary
EFD study);
• gravid uterine weights (OM
domain) for deriving gravid uterus
adjusted body weight; and
• pregnant, non-pregnant,
toxicokinetic females to illustrate in
Trial Design and pregnancy results (PC,
PP domains optional).
Please indicate in your request for
participation the extent to which your
submission will meet the above listed
criteria. Please also indicate whether
you are willing to share anonymized
data with the CDISC FFU team.
This pilot is intended to inform of the
readiness of the SEND–DART standard
6 See the FDA Study Data Resources web page,
available at https://www.fda.gov/ForIndustry/
DataStandards/StudyDataStandards/default.htm.
7 See the PhUSE Wiki web page, available at
https://www.phusewiki.org/wiki/
index.php?title=Nonclinical_Study_Data_
Reviewers_Guide.
8 See Footnote 6.
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17:35 Oct 21, 2020
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and support improvements to the
SEND–DART that will benefit FDA and
submitters. Pilot participants commit to
publicly share lessons learned with the
CDISC SEND team to ensure that the
CDISC SEND standard is improved for
the community. Participants may redact
any sensitive information as needed to
enable sharing FDA feedback with the
CDISC SEND team.
III. Requests for Participation
Requests to participate in the SEND–
DART FFU pilot are to be identified
with the Docket No. FDA–2020–N–
1806. Interested persons should include
the following information in the request:
Contact name, contact phone number,
email address, name of the sponsor, and
address, as well as the description of the
criteria met, addressing each of the
items in the Project participation
section.
Once requests for participation are
received CDER will contact interested
sponsors to discuss the pilot project and
clarify requirements and expectations.
The elapsed time duration of the pilot
is expected to be approximately 9
months but may be extended as needed.
Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23393 Filed 10–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Establishment 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: Proposed Establishment of the
Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC or Committee).
AGENCY:
In accordance with the
Federal Advisory Committee Act
(FACA) and section 1111 of the Public
Health Service (PHS) Act, HHS
announces the establishment of the
ACHDNC as a discretionary advisory
committee.
SUMMARY:
Mia
Morrison (DFO), Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301–
443–2521; or mmorrison@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
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67357
The
ACHDNC provides advice and
recommendations to the Secretary of
HHS on policy, program development,
and other matters of significance
concerning certain activities described
in section 1111 of the PHS Act (42
U.S.C. 300b–10), as further described
below. The ACHDNC is also governed
by the provisions of the FACA, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees. The
ACHDNC advises the Secretary of HHS
about aspects of newborn and childhood
screening and technical information for
the development of policies and
priorities that will enhance the ability of
the state and local health agencies to
provide for newborn and child
screening, counseling, and health care
services for newborns and children
having, or at risk for, heritable
disorders. The ACHDNC will review
and report regularly on newborn and
childhood screening practices,
recommend improvements in the
national newborn and childhood
screening programs, and fulfill
responsibilities described in section
1111 of the PHS Act. In addition, the
ACHDNC’s recommendations regarding
inclusion of additional conditions for
screening, following adoption by the
Secretary of HHS, are considered
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 PHS 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.
Notice of Establishment: In
accordance with the FACA and section
1111 of the PHS Act, (42 U.S.C. 300b–
10) the Secretary of HHS announces the
proposed establishment of the
ACHDNC.
It has been determined that the
formation of the ACHDNC is in the
public interest in connection with the
performance of duties imposed on the
Department of Health and Human
Services by law. A copy of the ACHDNC
charter can be accessed on the ACHDNC
website once available. A copy of the
charter also can be obtained, once
available, by accessing the FACA
SUPPLEMENTARY INFORMATION:
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67358
Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
database that is maintained by the
Committee Management Secretariat of
the General Services Administration.
The website address for this database is
https://www.facadatabase.gov/.
L609A, Washington, DC 20024; (202)
795–7622 or PACHA@hhs.gov.
Additional information can be obtained
by accessing the Council’s page on the
HIV.gov site at www.hiv.gov/pacha.
Maria G. Button,
Director, Executive Secretariat.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–23363 Filed 10–21–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice of a virtual meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will be
holding the 69th full Council meeting
utilizing virtual technology. PACHA
members will be discussing HIV, the
Ending the HIV Epidemic: A Plan for
America (EHE) initiative, and the novel
coronavirus (COVID–19). The meeting
will be open to the public; a public
comment session will be held during
the meeting. Pre-registration is required
to provide public comment. To preregister to attend or to provide public
comment, please send an email to
PACHA@hhs.gov and include your
name, organization, and title by close of
business Friday November 20, 2020. If
you decide you would like to provide
public comment but do not pre-register,
you may submit your written statement
by emailing PACHA@hhs.gov by close of
business Thursday, December 10, 2020.
The meeting agenda will be posted on
the PACHA page on HIV.gov at https://
www.hiv.gov/ federal-response/pacha/
about-pacha prior to the meeting.
DATES: The meeting will be held on
Wednesday, December 2 and Thursday,
December 3, 2020, from approximately
1:00 p.m. to 5:00 p.m. (ET) on both days.
This meeting will be conducted
utilizing virtual technology.
ADDRESSES: Instructions on attending
this meeting virtually will be posted one
week prior to the meeting at: https://
www.hiv.gov/federal-response/pacha/
about-pacha.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, MPA, Public Health
Analyst, Presidential Advisory Council
on HIV/AIDS, 330 C Street SW, Room
SUMMARY:
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17:35 Oct 21, 2020
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PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996 and is currently operating
under the authority given in Executive
Order 13889, dated September 27, 2019.
The Council was established to provide
advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective
prevention and care of HIV infection
and AIDS. The functions of the Council
are solely advisory in nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House.
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Engineering Immunity to
HIV–1 Through Next Generation Vaccines
(R61/R33 Clinical Trial Not Allowed).
Date: November 20, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 6701 Rockledge Drive, Room 1206,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Allergy and Infectious Diseases, National
Institutes of Health, 6701 Rockledge Drive,
Room 1206, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: October 16, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–23369 Filed 10–21–20; 8:45 am]
BILLING CODE 4140–01–P
Dated: October 15, 2020.
B. Kaye Hayes,
Principal Deputy Director, Office of Infectious
Disease and HIV/AIDS Policy, Executive
Director, Presidential Advisory Council on
HIV/AIDS, Office of the Assistant Secretary
for Health, Department of Health and Human
Services.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–23397 Filed 10–21–20; 8:45 am]
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 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.
BILLING CODE 4150–43–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 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
PO 00000
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National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Rational Design of Vaccines
Against Hepatitis C Virus (U19 Clinical Trial
Not Allowed).
Date: November 18–19, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
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]]>Agencies
[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Pages 67357-67358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23363]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Proposed Establishment 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: Proposed Establishment of the Advisory Committee on Heritable
Disorders in Newborns and Children (ACHDNC or Committee).
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act (FACA)
and section 1111 of the Public Health Service (PHS) Act, HHS announces
the establishment of the ACHDNC as a discretionary advisory committee.
FOR FURTHER INFORMATION CONTACT: Mia Morrison (DFO), Maternal and Child
Health Bureau, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301-
443-2521; or [email protected].
SUPPLEMENTARY INFORMATION: The ACHDNC provides advice and
recommendations to the Secretary of HHS on policy, program development,
and other matters of significance concerning certain activities
described in section 1111 of the PHS Act (42 U.S.C. 300b-10), as
further described below. The ACHDNC is also governed by the provisions
of the FACA, as amended (5 U.S.C. App.), which sets forth standards for
the formation and use of advisory committees. The ACHDNC advises the
Secretary of HHS about aspects of newborn and childhood screening and
technical information for the development of policies and priorities
that will enhance the ability of the state and local health agencies to
provide for newborn and child screening, counseling, and health care
services for newborns and children having, or at risk for, heritable
disorders. The ACHDNC will review and report regularly on newborn and
childhood screening practices, recommend improvements in the national
newborn and childhood screening programs, and fulfill responsibilities
described in section 1111 of the PHS Act. In addition, the ACHDNC's
recommendations regarding inclusion of additional conditions for
screening, following adoption by the Secretary of HHS, are considered
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 PHS 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.
Notice of Establishment: In accordance with the FACA and section
1111 of the PHS Act, (42 U.S.C. 300b-10) the Secretary of HHS announces
the proposed establishment of the ACHDNC.
It has been determined that the formation of the ACHDNC is in the
public interest in connection with the performance of duties imposed on
the Department of Health and Human Services by law. A copy of the
ACHDNC charter can be accessed on the ACHDNC website once available. A
copy of the charter also can be obtained, once available, by accessing
the FACA
[[Page 67358]]
database that is maintained by the Committee Management Secretariat of
the General Services Administration. The website address for this
database is https://www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-23363 Filed 10-21-20; 8:45 am]
BILLING CODE 4165-15-P
