Meeting of the Advisory Council on Blood Stem Cell Transplantation, 16104-16105 [2020-05921]
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Federal Register / Vol. 85, No. 55 / Friday, March 20, 2020 / Notices
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the guidance may be
sent. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Lauren Belcher or Annette Marthaler,
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373, email:
AskCTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Submission of Plans for Cigarette
Packages and Cigarette
Advertisements.’’ The Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act) (Pub. L. 111–31)
was enacted on June 22, 2009, and
granted FDA important new authority to
regulate the manufacture, marketing,
and distribution of tobacco products.
The Tobacco Control Act also amended
section 4 of the Federal Cigarette
Labeling and Advertising Act (FCLAA)
to direct FDA to issue regulations
requiring each cigarette package and
advertisement to bear a new textual
warning label statement accompanied
by color graphics depicting the negative
health consequences of smoking
(section 201 of the Tobacco Control
Act). In enacting this legislation,
Congress also provided that FDA may
adjust the required warnings if FDA
found that such a change would
promote greater public understanding of
the risks associated with the use of
tobacco products (section 202 of the
Tobacco Control Act). The Tobacco
Control Act also modified the
requirements of the FCLAA regarding
the submission of cigarette plans for the
random and equal display and
distribution of required warnings on
cigarette packages and quarterly rotation
of required warnings in cigarette
advertisements. It also requires that
such cigarette plans be submitted to
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FDA for review and approval, rather
than to the Federal Trade Commission.
FDA issued a rule entitled ‘‘Tobacco
Products; Required Warnings for
Cigarette Packages and Advertisements’’
on March 18, 2020. The rule specifies
the color graphics that must accompany
the new textual warning label
statements and establishes marketing
requirements for cigarette packages and
advertisements. The marketing
requirements include, among other
things, submission of a cigarette plan
that provides for the random and equal
display and distribution of the required
warnings on cigarette packages and
quarterly rotation of the required
warnings in cigarette advertisements, as
described under section 4 of FCLAA.
This guidance provides
recommendations related to preparing
and submitting those cigarette plans. It
discusses the regulatory requirements to
submit cigarette plans as well as:
• Who submits a cigarette plan;
• the scope of a cigarette plan;
• when to submit a cigarette plan;
• what information should be
submitted as part of a cigarette plan;
• where to submit a cigarette plan;
and
• what approval of a cigarette plan
means.
FDA previously published a draft
version of the guidance and sought
public comment (84 FR 71957,
December 30, 2019) (announcing the
availability of the draft guidance).
Among other things, comments express
some concerns, such as about printing
processes, as well as the difficulty of
achieving random and equal display
and distribution of required warnings.
FDA has considered the comments it
received, and included revisions in the
final guidance that: (1) Discuss, per the
final rule, that manufacturers may print
different required warnings on front and
rear panels of a cigarette package; (2)
recognize that some level of deviation is
appropriate given the language of the
FCLAA; and (3) provide updated
examples in an appendix to the
guidance that demonstrate how random
and equal display and distribution may
be achieved with various printing
methods, including those used by small
manufacturers.
II. Significance of Guidance
FDA is issuing this guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA regarding the
submission of cigarette plans for
cigarette packages and advertisements.
It does not establish any rights for any
person and is not binding on FDA or the
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public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to collections of
information described in FDA’s rule on
‘‘Tobacco Products; Required Warnings
for Cigarette Packages and
Advertisements,’’ which this guidance
is intended to interpret. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The information collection
provisions in the final rule have been
submitted to OMB for review as
required by section 3507(d) of the
Paperwork Reduction Act of 1995.
IV. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05936 Filed 3–19–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Council on
Blood Stem Cell Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT) has
scheduled a public meeting. Information
about ACBSCT and the agenda for this
meeting can be found on the ACBSCT
website at https://
bloodstemcell.hrsa.gov/about/advisorycouncil
DATES: April 27, 2020, 8:00 a.m.–4:00
p.m. Eastern Time (ET).
ADDRESSES: This meeting will be held
by webinar and conference call. The
webinar link, conference call-in
number, registration information, and
meeting materials can be accessed
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Federal Register / Vol. 85, No. 55 / Friday, March 20, 2020 / Notices
through the registration link on the
ACBSCT website at https://
bloodstemcell.hrsa.gov/about/advisorycouncil.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Center for Scientific Review; Notice of
Closed Meetings
Robert Walsh, Designated Federal
Official, (DFO), at Division of
Transplantation, HRSA, 5600 Fishers
Lane, 8W60, Rockville, Maryland 20857;
301–443–6839; or RWalsh@hrsa.gov.
ACBSCT
provides advice and recommendations
to the Secretary of HHS (Secretary) and
the HRSA Administrator on the
activities of the C.W. Bill Young Cell
Transplantation Program (CWBYCTP)
and the National Cord Blood Inventory
(NCBI) Program. The principal purpose
of these programs is to make blood stem
cells from adult donors and cord blood
units available for patients who need a
transplant to treat life-threatening
conditions such as leukemia, and who
lack a suitably matched relative who
can be the donor.
During the April 27, 2020, meeting,
the ACBSCT will discuss issues related
to increasing access to transplantation
(including the utilization of cord blood
and other types of cellular therapy).
Agenda items are subject to change as
priorities dictate. Refer to the ACBSCT
website for any updated information
concerning the meeting.
Members of the public 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 submit a written statement
or make oral comments to ACBSCT
should be sent to Robert Walsh, DFO,
using the contact information above at
least 3 business days prior to the
meeting.
Individuals planning to participate
who need special assistance or another
reasonable accommodation should
notify Robert Walsh at the address and
phone number listed above at least 10
business days prior to the meeting.
SUPPLEMENTARY INFORMATION:
Maria G. Button,
Director, Executive Secretariat.
jbell on DSKJLSW7X2PROD with NOTICES
[FR Doc. 2020–05921 Filed 3–19–20; 8:45 am]
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National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Myalgic
Encephalomyelitis/Chronic Fatigue
Syndrome.
Date: April 14, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: M. Catherine Bennett,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7846, Bethesda, MD 20892, (301) 435–
1766, bennettc3@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics in Human Aging.
Date: April 14, 2020.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 18–731
Cancer Workforce Diversity.
Date: April 16, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Reigh-Yi Lin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 827–6009, lin.reigh-yi@nih.gov.
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 16, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05816 Filed 3–19–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Diabetes and Digestive and Kidney
Diseases Special Emphasis Panel, March
30, 2020, 05:00 p.m. to March 31, 2020,
05:00 p.m., The Bethesdan Hotel,
Tapestry Collection by Hilton, 8120
Wisconsin Ave, Bethesda, MD, 20814
which was published in the Federal
Register on February 11, 2020, 85 FR
7772.
The meeting notice is amended to
change the Meeting Format from
Regular Meeting on March 30–31, 2020
to a Teleconference Meeting on March
30–31, 2020. The meeting is closed to
the public.
Dated: March 16, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05822 Filed 3–19–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development
Special Emphasis Panel, Fertility and
Infertility Preservation for Patients with
Diseases that Previously Precluded
Reproduction, April 15, 2020, 08:00
a.m. to April 15, 2020, 05:00 p.m.,
NICHD Offices, 6710B Rockledge Drive,
Bethesda, MD, 20892 which was
published in the Federal Register on
March 06, 2020, 85 FR 10707.
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]]>Agencies
[Federal Register Volume 85, Number 55 (Friday, March 20, 2020)]
[Notices]
[Pages 16104-16105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05921]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Council on Blood Stem Cell
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, this
notice announces that the Secretary's Advisory Council on Blood Stem
Cell Transplantation (ACBSCT) has scheduled a public meeting.
Information about ACBSCT and the agenda for this meeting can be found
on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/advisory-council
DATES: April 27, 2020, 8:00 a.m.-4:00 p.m. Eastern Time (ET).
ADDRESSES: This meeting will be held by webinar and conference call.
The webinar link, conference call-in number, registration information,
and meeting materials can be accessed
[[Page 16105]]
through the registration link on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/advisory-council.
FOR FURTHER INFORMATION CONTACT: Robert Walsh, Designated Federal
Official, (DFO), at Division of Transplantation, HRSA, 5600 Fishers
Lane, 8W60, Rockville, Maryland 20857; 301-443-6839; or
[email protected].
SUPPLEMENTARY INFORMATION: ACBSCT provides advice and recommendations
to the Secretary of HHS (Secretary) and the HRSA Administrator on the
activities of the C.W. Bill Young Cell Transplantation Program
(CWBYCTP) and the National Cord Blood Inventory (NCBI) Program. The
principal purpose of these programs is to make blood stem cells from
adult donors and cord blood units available for patients who need a
transplant to treat life-threatening conditions such as leukemia, and
who lack a suitably matched relative who can be the donor.
During the April 27, 2020, meeting, the ACBSCT will discuss issues
related to increasing access to transplantation (including the
utilization of cord blood and other types of cellular therapy). Agenda
items are subject to change as priorities dictate. Refer to the ACBSCT
website for any updated information concerning the meeting.
Members of the public 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
submit a written statement or make oral comments to ACBSCT should be
sent to Robert Walsh, DFO, using the contact information above at least
3 business days prior to the meeting.
Individuals planning to participate who need special assistance or
another reasonable accommodation should notify Robert Walsh 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. 2020-05921 Filed 3-19-20; 8:45 am]
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