Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public Workshop; Remote Only, 23968 [2020-09168]
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23968
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2017–N–6644]
[Docket No. FDA–2017–D–2834]
Fiscal Year 2020 Generic Drug
Regulatory Science Initiatives; Public
Workshop; Remote Only
Extension of Certain Tobacco Product
Compliance Deadlines Related to the
Final Deeming Rule; Withdrawal of
Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration is announcing that the
following public workshop entitled ‘‘FY
2020 Generic Drug Regulatory Science
Initiatives’’ announced in the Federal
Register on March 10, 2020, is being
modified to take place remotely.
SUMMARY:
The public workshop will be
held on May 4, 2020, from 8:30 a.m. to
4:30 p.m. Submit either electronic or
written comments on this public
workshop by June 4, 2020. See the
SUPPLEMENTARY INFORMATION section for
registration and participation
information.
DATES:
FOR FURTHER INFORMATION CONTACT:
Stephanie Choi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4732,
Silver Spring, MD 20993–0002, 240–
402–7960, Stephanie.Choi@fda.hhs.gov;
or Robert Lionberger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722,
Silver Spring, MD 20993, 240–402–
7957, Robert.Lionberger@fda.hhs.gov.
Due to the
ongoing COVID–19 pandemic, this
workshop announced in the Federal
Register on March 10, 2020 (85 FR
13905) is being changed from in person
to remote only. How to register and
participate in this remote meeting will
be communicated on the FDA web page
at the following address: https://
www.fda.gov/news-events/fda-meetingsconferences-and-workshops/fy-2020generic-drug-regulatory-scienceinitiatives-public-workshop-0504202005042020.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09168 Filed 4–29–20; 8:45 am]
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Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing the withdrawal of a
guidance for industry entitled
‘‘Extension of Certain Tobacco Product
Compliance Deadlines Related to the
Final Deeming Rule,’’ which was issued
in 2017. The guidance was intended to
assist persons who manufacture,
package, sell, offer to sell, distribute, or
import for sale and distribution within
the United States newly regulated
tobacco products, roll-your-own (RYO)
tobacco, and cigarette tobacco in
complying with the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), and FDA
regulations. FDA is withdrawing the
guidance because the compliance
deadlines contained therein have
passed, have been vacated or stayed, or
are otherwise described in other
guidance.
The withdrawal is applicable
April 30, 2020.
FOR FURTHER INFORMATION CONTACT: Eric
C. Mandle, Center for Tobacco Products,
Food and Drug Administration, 10903
New Hampshire Ave., Document
Control Center, Bldg. 71, Rm. G335,
Silver Spring, MD 20993–0002; 1–877–
287–1373, CTPRegulations@
fda.hhs.gov.
DATES:
FDA is
withdrawing the guidance for industry
entitled ‘‘Extension of Certain Tobacco
Product Compliance Deadlines Related
to the Final Deeming Rule,’’ which was
issued in 2017 (see 82 FR 37459 (August
10, 2017)) and which has been revised
several times since then. The guidance
was intended to assist persons who
manufacture, package, sell, offer to sell,
distribute, or import for sale and
distribution within the United States
newly regulated tobacco products, RYO
tobacco, and cigarette tobacco in
complying with the FD&C Act, as
amended by the Tobacco Control Act,
and FDA regulations.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
The Tobacco Control Act (Pub. L.
111–31) granted FDA the authority to
immediately regulate the manufacture,
marketing, and distribution of cigarettes,
cigarette tobacco, RYO, and smokeless
tobacco products to protect the public
health and to reduce tobacco use by
minors.
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b))
of the FD&C Act). On May 10, 2016,
FDA issued that rule, extending FDA’s
tobacco product authority to all
products that meet the definition of
tobacco product in the law (except for
accessories of newly regulated tobacco
products), including electronic nicotine
delivery systems, cigars, hookah, pipe
tobacco, nicotine gels, dissolvables that
were not already subject to the FD&C
Act, and other tobacco products that
may be developed in the future (81 FR
28974 at 28976) (‘‘the final deeming
rule’’).
In May 2017, FDA published the first
edition of this guidance, under which it
provided a 3-month extension of all
future compliance deadlines under the
final deeming rule. The second edition
of the guidance, published in August
2017, revised and updated the first
edition by further extending certain of
the future compliance dates.
On May 15, 2019, the U.S. District
Court for the District of Maryland issued
an order vacating the extended
compliance dates for premarket review
in the guidance.1 On July 12, 2019, the
court issued an order directing FDA to
require that premarket authorization
applications for all new—i.e., not
‘‘grandfathered’’ 2—deemed tobacco
products to be submitted to the Agency
within 10 months, by May 12, 2020, and
providing for a 1-year period during
which products with timely filed
applications might remain on the
market pending FDA review.3 As
1 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., 379 F.Supp.3d 461
(D. Md. 2019).
2 A ‘‘grandfathered’’ product is one that was on
the market as of February 15, 2007. ‘‘Guidance for
Industry, Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of
February 15, 2007,’’ dated September 2014,
available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
establishing-tobacco-product-was-commerciallymarketed-united-states-february-15-2007.
3 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., 399 F.Supp.3d 479
(D. Md. 2019). The court has granted intervention
to vapor industry trade associations for purposes of
appealing the court’s decision and remedies order.
See American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., No. 8:18–cv–883
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[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Page 23968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09168]
[[Page 23968]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6644]
Fiscal Year 2020 Generic Drug Regulatory Science Initiatives;
Public Workshop; Remote Only
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is announcing that the
following public workshop entitled ``FY 2020 Generic Drug Regulatory
Science Initiatives'' announced in the Federal Register on March 10,
2020, is being modified to take place remotely.
DATES: The public workshop will be held on May 4, 2020, from 8:30 a.m.
to 4:30 p.m. Submit either electronic or written comments on this
public workshop by June 4, 2020. See the SUPPLEMENTARY INFORMATION
section for registration and participation information.
FOR FURTHER INFORMATION CONTACT: Stephanie Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4732, Silver Spring, MD 20993-0002, 240-
402-7960, [email protected]; or Robert Lionberger, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957, [email protected].
SUPPLEMENTARY INFORMATION: Due to the ongoing COVID-19 pandemic, this
workshop announced in the Federal Register on March 10, 2020 (85 FR
13905) is being changed from in person to remote only. How to register
and participate in this remote meeting will be communicated on the FDA
web page at the following address: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fy-2020-generic-drug-regulatory-science-initiatives-public-workshop-05042020-05042020.
Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09168 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P
