Meeting of the National Advisory Committee on Rural Health and Human Services, 54983-54984 [2021-21581]
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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Notices
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The draft guidance may
also be obtained by mail by calling
CBER at 1–800–835–4709 or 240–402–
8010. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Timothy
McGovern, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6426, Silver Spring,
MD 20993–0002, 240–402–0477,
Timothy.McGovern@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
Regarding the ICH: Jill Adleberg,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6364, Silver Spring,
MD 20993–0002, 301–796–5259,
Jill.Adleberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘S1B(R1) Addendum to S1B Testing for
Carcinogenicity of Pharmaceuticals’’.
The guidance was prepared under the
auspices of ICH. ICH has the mission of
achieving greater regulatory
harmonization worldwide to ensure that
safe, effective, high-quality medicines
are developed, registered, and
maintained in the most resourceefficient manner.
By harmonizing the regulatory
requirements in regions around the
world, ICH guidelines have
substantially reduced duplicative
clinical studies, prevented unnecessary
animal studies, standardized the
reporting of important safety
information, standardized marketing
application submissions, and made
many other improvements in the quality
of global drug development and
manufacturing and the products
available to patients.
The six Founding Members of the ICH
are FDA; the Pharmaceutical Research
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and Manufacturers of America; the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; and the
Japanese Pharmaceutical Manufacturers
Association. The Standing Members of
the ICH Association include Health
Canada and Swissmedic. Additionally,
the Membership of ICH has expanded to
include other regulatory authorities and
industry associations from around the
world (refer to https://www.ich.org/).
ICH works by involving technical
experts from both regulators and
industry parties in detailed technical
harmonization work and the application
of a science-based approach to
harmonization through a consensusdriven process that results in the
development of ICH guidelines. The
regulators around the world are
committed to consistently adopting
these consensus-based guidelines,
realizing the benefits for patients and for
industry.
As a Founding Regulatory Member of
ICH, FDA plays a major role in the
development of each of the ICH
guidelines, which FDA then adopts and
issues as guidance for industry. FDA’s
guidance documents do not establish
legally enforceable responsibilities.
Instead, they describe the Agency’s
current thinking on a topic and should
be viewed only as recommendations,
unless specific regulatory or statutory
requirements are cited.
In May 2021, the ICH Assembly
endorsed the draft guideline entitled
‘‘S1B(R1) Addendum to S1B Testing for
Carcinogenicity of Pharmaceuticals’’
and agreed that the guideline should be
made available for public comment. The
draft guideline is the product of the
Safety Expert Working Group of the
ICH. Comments about this draft will be
considered by FDA and the Safety
Expert Working Group.
The draft guidance provides guidance
on expanding the testing scheme for
assessing human carcinogenic risk of
small molecule pharmaceuticals by
introducing an additional approach that
is not described in the original S1B
Guideline and also adds a plasma
exposure ratio-based approach for
setting the high dose in the rasH2-Tg
mouse model.
This draft guidance has been left in
the original ICH format. The final
guidance will be reformatted and edited
to conform with FDA’s good guidance
practices regulation (21 CFR 10.115) and
style before publication. The draft
guidance, when finalized, will represent
the current thinking of FDA on
‘‘S1B(R1) Addendum to S1B Testing for
Carcinogenicity of Pharmaceuticals’’. It
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54983
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 requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections 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 for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at
https://www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21692 Filed 10–4–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Committee on Rural Health and Human
Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces the Secretary’s
National Advisory Committee on Rural
Health and Human Services
(NACRHHS) has scheduled a public
meeting. Information about NACRHHS
SUMMARY:
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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Notices
and the agenda for this meeting can be
found on the NACRHHS website at
https://www.hrsa.gov/advisorycommittees/rural-health/.
DATES:
• Monday, October 25, 2021, 12:00
p.m.–5:30 p.m. Eastern Time (ET);
• Tuesday, October 26, 2021, 12:30
p.m.–4:15 p.m. ET; and
• Wednesday, October 27, 2021,
12:30 p.m.–4:30 p.m. ET.
FOR FURTHER INFORMATION CONTACT:
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Steven Hirsch, Administrative
Coordinator at the Federal Office of
Rural Health Policy, HRSA, 5600
Fishers Lane, 17W59D, Rockville,
Maryland 20857; (301) 443–7322; or
shirsch@hrsa.gov.
SUPPLEMENTARY INFORMATION:
NACRHHS provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning both rural
health and rural human services.
At this meeting, NACRHHS will
discuss Behavioral Health and Primary
Care Integration in Rural America and
recommendations to the Secretary on
designation of a new type of provider,
the Rural Emergency Hospital.
Members of the public will have the
opportunity to provide comments.
Public participants wishing to provide
oral comments must submit a written
version of their statement at least three
business days in advance of the
scheduled meeting. Oral comments will
be honored in the order they are
requested and may be limited as time
permits. Public participants wishing to
offer a written statement should send it
to Steven Hirsch, using the contact
information above, at least 3 business
days prior to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Steven Hirsch at the address and
phone number listed above at least 10
business days prior to the meeting.
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Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.surveymonkey.com/r/
WLSYQS5 by the deadline of 12:00 p.m.
ET on October, 24, 2021. Instructions on
how to access the meeting via Zoom
will be provided upon registration.
[FR Doc. 2021–21581 Filed 10–4–21; 8:45 am]
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
ADDRESSES:
Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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. Information
about ACHDNC and the agenda for this
meeting can be found on ACHDNC
website at https://www.hrsa.gov/
advisory-committees/heritabledisorders/.
DATES: Tuesday, November 9, 2021,
from 10:00 a.m. to 3:00 p.m. Eastern
Time (ET) and Wednesday, November
10, 2021, from 10:00 a.m. to 3:00 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.achdncmeetings.org/registration/
by 12:00 p.m. ET on November 8, 2021.
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
ACHDNC@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of Health and Human
Services (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. 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 on
the Recommended Uniform Screening
Panel, following adoption by the
SUMMARY:
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Secretary, are evidence-informed
preventive health services provided for
in the comprehensive guidelines
supported by HRSA 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 1 year from
the Secretary’s adoption of the
condition for screening.
During the November 9–10, 2021,
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) The Committee will vote on
whether or not to approve the following
updates to the Committee’s evidencebased review and decision-making
process: The condition nomination
form, methods for assessing published
and unpublished evidence, and
additional guidance for the Committee’s
decision matrix.
(2) A presentation on phase two of the
Mucopolysaccharidosis type II evidence
review;
(3) A presentation on phase one of the
Guanidinoacetate methyltransferase
deficiency evidence review;
(4) A Krabbe disease nomination
overview;
(5) A possible Committee vote on
whether to move Krabbe disease
forward to a full evidence review; and
(6) Workgroup updates.
The agenda for this meeting does not
include any vote or decision to
recommend a condition for inclusion in
the Recommended Uniform Screening
Panel. As noted in the agenda items, the
Committee may hold a vote on whether
or not to recommend a nominated
condition (Krabbe disease) to full
evidence review, and will hear
presentations on evidence review of
Mucopolysaccharidosis type II and
Guanidinoacetate methyltransferase
deficiency, any of which may lead to
such a recommendation at a future time.
Agenda items are subject to change as
priorities dictate. Information about
ACHDNC, including a roster of members
and past meeting summaries, is also
available on the ACHDNC website.
Members of the public also will have
the opportunity to provide comments.
Public participants providing general
oral comments may submit written
statements in advance of the scheduled
meeting. Oral comments will be
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]]>Agencies
[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54983-54984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21581]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the National Advisory Committee on Rural Health and
Human Services
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, this
notice announces the Secretary's National Advisory Committee on Rural
Health and Human Services (NACRHHS) has scheduled a public meeting.
Information about NACRHHS
[[Page 54984]]
and the agenda for this meeting can be found on the NACRHHS website at
https://www.hrsa.gov/advisory-committees/rural-health/.
DATES:
Monday, October 25, 2021, 12:00 p.m.-5:30 p.m. Eastern
Time (ET);
Tuesday, October 26, 2021, 12:30 p.m.-4:15 p.m. ET; and
Wednesday, October 27, 2021, 12:30 p.m.-4:30 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.surveymonkey.com/r/WLSYQS5 by the deadline of
12:00 p.m. ET on October, 24, 2021. Instructions on how to access the
meeting via Zoom will be provided upon registration.
FOR FURTHER INFORMATION CONTACT: Steven Hirsch, Administrative
Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600
Fishers Lane, 17W59D, Rockville, Maryland 20857; (301) 443-7322; or
[email protected].
SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations
to the Secretary of HHS (Secretary) on policy, program development, and
other matters of significance concerning both rural health and rural
human services.
At this meeting, NACRHHS will discuss Behavioral Health and Primary
Care Integration in Rural America and recommendations to the Secretary
on designation of a new type of provider, the Rural Emergency Hospital.
Members of the public will have the opportunity to provide
comments. Public participants wishing to provide oral comments must
submit a written version of their statement at least three business
days in advance of the scheduled meeting. Oral comments will be honored
in the order they are requested and may be limited as time permits.
Public participants wishing to offer a written statement should send it
to Steven Hirsch, using the contact information above, at least 3
business days prior to the meeting.
Individuals who plan to attend and need special assistance or
another reasonable accommodation should notify Steven Hirsch at the
address and phone number listed above at least 10 business days prior
to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-21581 Filed 10-4-21; 8:45 am]
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