Correction to Establishment and Solicitation of Nominations for Tribal Advisory Council, 23974 [2020-09229]
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23974
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
0002, email: CTPRegulations@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Enforcement Priorities for Electronic
Nicotine Delivery Systems (ENDS) and
Other Deemed Products on the Market
Without Premarket Authorization
(Revised).’’
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Pub. L. 111–
31) (Tobacco Control Act) into law. The
Tobacco Control Act grants FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health
generally and to reduce tobacco use by
minors. The Tobacco Control Act also
gave FDA the authority to issue
regulations deeming other products that
meet the statutory definition of a
tobacco product to be subject to chapter
IX of the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
In accordance with that authority, on
May 10, 2016, FDA issued a final rule
entitled ‘‘Deeming Tobacco Products to
be Subject to the Federal Food, Drug,
and Cosmetic Act, as Amended by the
Family Smoking Prevention and
Tobacco Control Act: Restrictions on the
Sale and Distribution of Tobacco
Products and Required Warning
Statements for Tobacco Products’’ (the
final deeming rule) deeming all
products that meet the statutory
definition of a tobacco product, except
accessories of deemed tobacco products,
to be subject to FDA’s tobacco product
authority. This included ENDS, cigars,
waterpipe (hookah) tobacco, pipe
tobacco, nicotine gels, and dissolvables
that were not already subject to the
FD&C Act (81 FR 28974 at 28976, May
10, 2016).
The requirements in chapter IX of the
FD&C Act (21 U.S.C. 387 through 387u)
now apply to deemed tobacco products.
This includes section 910 (21 U.S.C.
387j), which imposes certain premarket
review requirements for ‘‘new tobacco
products’’—i.e., those that were not
commercially marketed in the United
States as of February 15, 2007.
Accordingly, after the rule’s effective
date, deemed new tobacco products
were required to obtain premarket
authorization under section 910 of the
FD&C Act. Deemed new tobacco
products that remain on the market
without marketing authorization are
marketed unlawfully in contravention of
the Tobacco Control Act.
On January 2, 2020, FDA issued a
final guidance entitled ‘‘Enforcement
VerDate Sep<11>2014
18:56 Apr 29, 2020
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Priorities for Electronic Nicotine
Delivery Systems (ENDS) and Other
Deemed Products on the Market
Without Premarket Authorization’’ to
communicate its enforcement priorities
with respect to ENDS products (January
7, 2020; 85 FR 720) (available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
enforcement-priorities-electronicnicotine-delivery-system-ends-andother-deemed-products-market). It also
stated that manufacturers of other
deemed tobacco products would be
required to submit marketing
applications for those products by May
12, 2020.
On April 22, 2020, the court granted
a motion for a 120-day extension (until
September 9, 2020) in light of the global
outbreak of respiratory illness caused by
a new coronavirus.1 Accordingly, FDA
is revising the guidance to change the
date required to submit premarket
authorization applications to the
Agency from May 12, 2020, to
September 9, 2020.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of the Agency’s enforcement
priorities with respect to ENDS products
and the submission of marketing
applications for other deemed tobacco
products. 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
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
This final guidance refers to
previously approved FDA collections of
information. 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
collections of information in 21 CFR
1107.1(b) and (c) have been approved
under OMB control number 0910–0684;
the collections of information under
section 910 of the FD&C Act have been
approved under OMB control number
0910–0768. The collections of
information in section 905(j) of the
FD&C Act (21 U.S.C. 387e(j)) have been
approved under OMB control number
0910–0673.
1 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., Case No. 8:18–cv–
883 (PWG), (D. Md. April 22, 2020), Dkt. No. 182.
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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/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09164 Filed 4–29–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Correction to Establishment and
Solicitation of Nominations for Tribal
Advisory Council
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice; correction.
AGENCY:
SUMMARY: HRSA is soliciting comments
and recommendations regarding HRSA’s
intent to establish the HRSA Tribal
Advisory Council (TAC) and is seeking
nominations of qualified tribal officials
as candidates for consideration for
appointment as voluntary delegate
members of the HRSA TAC. Due to
delays caused by the global impact of
the Coronavirus Disease 2019 (COVID–
19), HRSA is extending the deadline for
the submissions of nominations of
qualified tribal officials for
consideration for appointment as
voluntary delegate members of the
HRSA TAC. Nominations for
membership must now be received on
or before July 6, 2020. This 60-day
extension will allow tribes and tribal
serving organizations the additional
time needed to identify qualified tribal
officials as candidates and submit
comprehensive nomination packages.
FOR FURTHER INFORMATION CONTACT:
CAPT Elijah K. Martin, Jr. EdD, MPH,
Manager, Tribal Health Affairs, Office of
Health Equity, HRSA, 5600 Fishers
Lane, Room 13N44, Rockville, Maryland
20857, 301–443–7526, aianhealth@
hrsa.gov.
Correction—Due to COVID–19, HRSA
OHE is extending the deadline for HRSA
TAC membership nominations by 60
days from May 7, 2020, to July 6, 2020.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–09229 Filed 4–29–20; 8:45 am]
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[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Page 23974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09229]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Correction to Establishment and Solicitation of Nominations for
Tribal Advisory Council
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: HRSA is soliciting comments and recommendations regarding
HRSA's intent to establish the HRSA Tribal Advisory Council (TAC) and
is seeking nominations of qualified tribal officials as candidates for
consideration for appointment as voluntary delegate members of the HRSA
TAC. Due to delays caused by the global impact of the Coronavirus
Disease 2019 (COVID-19), HRSA is extending the deadline for the
submissions of nominations of qualified tribal officials for
consideration for appointment as voluntary delegate members of the HRSA
TAC. Nominations for membership must now be received on or before July
6, 2020. This 60-day extension will allow tribes and tribal serving
organizations the additional time needed to identify qualified tribal
officials as candidates and submit comprehensive nomination packages.
FOR FURTHER INFORMATION CONTACT: CAPT Elijah K. Martin, Jr. EdD, MPH,
Manager, Tribal Health Affairs, Office of Health Equity, HRSA, 5600
Fishers Lane, Room 13N44, Rockville, Maryland 20857, 301-443-7526,
[email protected].
Correction--Due to COVID-19, HRSA OHE is extending the deadline for
HRSA TAC membership nominations by 60 days from May 7, 2020, to July 6,
2020.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-09229 Filed 4-29-20; 8:45 am]
BILLING CODE 4165-15-P
