Charter Renewal for the Advisory Committee on Organ Transplantation, 55304-55305 [2020-19644]
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Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Notices
the liver, and glomerular filtration and
tubular secretion of unchanged drug by
the kidneys (i.e., renal excretion). If a
drug is eliminated primarily through
renal excretion, then impaired renal
function usually alters the drug’s PK to
an extent that the dosage regimen may
need to be changed from that used in
patients with normal renal function. For
most drugs that are likely to be
administered to patients with impaired
renal function, it is important to
characterize PK in subjects with
impaired renal function to provide
appropriate dosing recommendations.
The safety and efficacy of a drug are
generally established for a particular
dosage regimen (or range of dosage
regimens) in late-phase clinical trials
that enroll patients from the target
patient population. Frequently,
however, individuals with advanced
kidney disease are explicitly excluded
from participation in these studies,
hindering the assessment of the effects
of severely impaired kidney function on
the PK of a drug or the patient’s clinical
response. A well-planned drug
development program can enable
prospective dosage adjustment based on
the observed or expected changes in the
PK of a drug due to impaired renal
function prior to initiating phase 2 or
phase 3 trials.
This guidance replaces the 2010
version and provides updated
recommendations on the following
topics:
(1) When a dedicated study of a drug’s
PK in subjects with impaired renal
function is recommended and when it
may not be needed;
(2) The design and conduct of
pharmacokinetic studies in subjects
with impaired renal function;
(3) Considerations for characterizing a
drug’s PK in patients undergoing
intermittent or continuous dialytic
therapies;
(4) The use of pharmacokinetic
information from phase 2 and 3 studies
to inform dosing recommendations for
patients with renal impairment; and
(5) The analysis and reporting of the
results of studies that characterize the
impact of renal impairment and how
these data inform dosing.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Pharmacokinetics in Patients with
Impaired Renal Function—Study
Design, Data Analysis, and Impact on
Dosing.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
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requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this draft guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by
OMB under the PRA. The collection of
information in 21 CFR 201.57 has been
approved under OMB control number
0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: August 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19597 Filed 9–3–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that VILTEPSO
(viltolarsen) manufactured by Nippon
Shinyaku Co., Ltd. (NS Pharma Inc.,
U.S. Agent), meets the criteria for a
priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
SUMMARY:
PO 00000
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and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that VILTEPSO
(viltolarsen) manufactured by Nippon
Shinyaku Co., Ltd. (NS Pharma Inc.,
U.S. Agent), meets the criteria for a
priority review voucher.
VILTEPSO (viltolarsen) is indicated
for the treatment of Duchenne Muscular
Dystrophy in patients amenable to Exon
53 Skipping.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsfor
RareDiseasesConditions/
RarePediatricDiseasePriorityVoucher
Program/default.htm. FOR FURTHER
INFORMATION about VILTEPSO
(viltolarsen) go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: August 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19604 Filed 9–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act
(FACA), HHS is hereby giving notice
that the Advisory Committee on Organ
Transplantation (ACOT) has been
renewed. The effective date of the
renewed charter is August 31, 2020.
FOR FURTHER INFORMATION CONTACT:
Robert Walsh, Designated Federal
Officer, HRSA Division of
SUMMARY:
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Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Notices
Transplantation, Healthcare Systems
Bureau, HRSA, 5600 Fishers Lane,
Room 08W60, Rockville, Maryland
20857; 301–443–6839; or rwalsh@
hrsa.gov.
Request for advisory committee
member nominations.
ACTION:
The ACOT
provides advice and recommendations
to the Secretary of HHS (Secretary) on
all aspects of organ donation,
procurement, allocation, and
transplantation, and on such other
matters that the Secretary determines.
ACOT is authorized by 42 U.S.C. 217a;
Section 222 of the Public Health Service
Act, as amended; 42 CFR 121.12.
The Committee is governed by
provisions of the FACA, Public Law 92–
463 (5 U.S.C. App. 2), which sets forth
standards for the formation of advisory
committees. The recommendations of
the ACOT inform HHS programs and
activities to support organ donation and
transplantation. ACOT’s recent
recommendations in support of
expanding reimbursement of living
organ donor expenses were cited as a
key part of the rationale for recent
proposed HHS actions to expand this
activity consistent with the President’s
Executive Order on Advancing
American Kidney Health. The charter
renewal for the ACOT was approved on
August 31, 2020, which will also stand
as the filing date. Renewal of the ACOT
charter gives authorization for the
committee to operate until August 31,
2022.
A copy of the ACOT charter is
available on the ACOT website at
https://www.organdonor.gov/about-dot/
acot.html. A copy of the charter also can
be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The website address for
the FACA database is https://
www.facadatabase.gov/.
SUPPLEMENTARY INFORMATION:
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–19644 Filed 9–3–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Heritable Disorders in
Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
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HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC or Committee). The
Committee provides advice,
recommendations, and technical
information about aspects of heritable
disorders and newborn and childhood
screening to the Secretary of HHS
(Secretary). HRSA is seeking
nominations of qualified candidates for
appointment to five positions on the
Committee for terms of up to 4 years.
DATES: Written nominations for
membership on the Committee must be
received on or before September 22,
2020.
SUMMARY:
Nomination packages must
be submitted electronically as email
attachments to Mia Morrison, MPH at
ACHDNC@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Mia
Morrison, MPH, Maternal and Child
Health Bureau, HRSA 5600 Fishers
Lane, Room 18W–68, Rockville, MD
20857; 301–443–2521; or ACHDNC@
hrsa.gov. A copy of the Committee
charter and list of the current
membership may be obtained by
accessing the Committee website at
https://www.hrsa.gov/sites/default/files/
hrsa/advisory-committees/heritabledisorders/about/members.pdf.
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.
In addition, the Committee provides
advice and recommendations to the
Secretary concerning grants, projects
and technical information to develop
policies and priorities for grants,
including those 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 Committee meets four times each
calendar year, or at the discretion of the
Designated Federal Officer in
consultation with the ACHDNC Chair.
The Committee is governed by the
provisions of Federal Advisory
Committee Act, as amended (5 U.S.C.
App. 2), and 41 CFR part 102–3, which
set forth standards for the formation and
ADDRESSES:
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55305
use of advisory committees, and its
Charter.
The Committee reviews and reports
regularly on newborn and childhood
screening practices for heritable
disorders, recommends improvements
in the national newborn and childhood
heritable screening programs, and
recommends conditions for inclusion in
the Recommended Uniform Screening
Panel (RUSP). The Committee’s
recommendations regarding additional
conditions/inherited disorders for
screening that have been adopted by the
Secretary are included in the RUSP and
constitute part of the comprehensive
guidelines supported by HRSA pursuant
to section 2713 of the PHS Act, codified
at 42 U.S.C. 300gg–13. Under this
provision, non-grandfathered health
plans and group and individual health
insurance issuers are required to cover
screenings included in the HRSAsupported comprehensive guidelines
without charging a co-payment, coinsurance, or deductible for plan years
(i.e., in the individual market, policy
years) beginning on or after the date that
is 1 year from the Secretary’s adoption
of the condition for screening.
Nominations
HRSA is requesting nominations for
voting members to serve on the
Committee to fill up to five positions for
terms of up-to 4 years. The Secretary
appoints Committee members with the
expertise needed to fulfill the duties of
the Advisory Committee. Nominees
sought are medical, technical, or
scientific professionals with special
expertise in the field of heritable
disorders or in providing screening,
counseling, testing, or specialty services
for newborns and children with, or at
risk for having, heritable disorders;
individuals who have expertise in ethics
(e.g., bioethics) and infectious diseases
and who have worked and published
material in the area of newborn
screening; members of the public having
demonstrated expertise about or
concern with heritable disorders; and/or
representatives from such federal
agencies, public health constituencies,
and medical professional societies with
such expertise. Interested applicants
may self-nominate or be nominated by
another individual or organization.
Nominees must reside in the United
States and cannot be funded for
international travel expenses.
Individuals selected for appointment
to the Committee will be invited to
serve for up-to 4 years. Members who
are not federal officers or permanent
federal employees are appointed as
special government employees and
receive a stipend and reimbursement for
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]]>Agencies
[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55304-55305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19644]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Charter Renewal for the Advisory Committee on Organ
Transplantation
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act (FACA),
HHS is hereby giving notice that the Advisory Committee on Organ
Transplantation (ACOT) has been renewed. The effective date of the
renewed charter is August 31, 2020.
FOR FURTHER INFORMATION CONTACT: Robert Walsh, Designated Federal
Officer, HRSA Division of
[[Page 55305]]
Transplantation, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane,
Room 08W60, Rockville, Maryland 20857; 301-443-6839; or
[email protected].
SUPPLEMENTARY INFORMATION: The ACOT provides advice and recommendations
to the Secretary of HHS (Secretary) on all aspects of organ donation,
procurement, allocation, and transplantation, and on such other matters
that the Secretary determines. ACOT is authorized by 42 U.S.C. 217a;
Section 222 of the Public Health Service Act, as amended; 42 CFR
121.12.
The Committee is governed by provisions of the FACA, Public Law 92-
463 (5 U.S.C. App. 2), which sets forth standards for the formation of
advisory committees. The recommendations of the ACOT inform HHS
programs and activities to support organ donation and transplantation.
ACOT's recent recommendations in support of expanding reimbursement of
living organ donor expenses were cited as a key part of the rationale
for recent proposed HHS actions to expand this activity consistent with
the President's Executive Order on Advancing American Kidney Health.
The charter renewal for the ACOT was approved on August 31, 2020, which
will also stand as the filing date. Renewal of the ACOT charter gives
authorization for the committee to operate until August 31, 2022.
A copy of the ACOT charter is available on the ACOT website at
https://www.organdonor.gov/about-dot/acot.html. A copy of the charter
also can be obtained by accessing the FACA database that is maintained
by the Committee Management Secretariat under the General Services
Administration. The website address for the FACA database is https://www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-19644 Filed 9-3-20; 8:45 am]
BILLING CODE 4165-15-P
