March 10 Through April 30, 2020, Public Meetings; Postponement, Cancellation, or Remote Only, 15789-15790 [2020-05743]
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Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
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. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Lubna Merchant, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4418,
Silver Spring, MD 20993, 301–796–
3600; 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, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
I. Background
In the Federal Register of June 1,
2018, FDA published a notice with a 60day comment period to request
comments on the draft guidance for
industry entitled ‘‘Development of
Shared System REMS.’’ This draft
guidance describes some of the possible
benefits of a shared system REMS and
provides general principles and
recommendations to assist industry
with the development of these
programs. Section 610 of the Further
Consolidated Appropriations Act, 2020
(Pub. L. 116–94, 133 Stat. 3524
(December 20, 2019)), amended section
505–1(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351–1(i)),
regarding the requirement that a drug
that is the subject of an abbreviated new
drug application (ANDA) and its
reference listed drug use a single, shared
system for the elements to assure safe
use unless FDA waives that
requirement. We intend to revise the
draft guidance accordingly. The Agency
continues to recognize that shared
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system REMS may be in the interest of
public health.
FDA is reopening the comment period
until May 18, 2020. FDA is interested in
receiving additional input regarding any
further steps the Agency could take to
facilitate successful formation of shared
system REMS. In particular, FDA is
seeking comment on the challenges and
successes with: (1) Negotiating
governance agreements among parties
involved in a shared system REMS and
(2) developing effective shared system
REMS programs. The Agency believes
that an additional 60 days will allow
adequate time for interested persons to
submit comments without
compromising the timely publication of
the final version of the guidance.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05712 Filed 3–18–20; 8:45 am]
BILLING CODE 4164–01–P
ACTION:
15789
Notice.
The Food and Drug
Administration is announcing that
certain meetings involving the Center
for Drug Evaluation and Research
(CDER) from March 10 through April 30,
2020, are postponed, cancelled, or
modified to take place remotely.
SUMMARY:
For dates that have been either
postponed or cancelled, see table 1 in
the SUPPLEMENTARY INFORMATION section.
DATES:
Kim
Thomas, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6282, Silver Spring,
MD 20993–0002, 301–796–2357,
Kimberly.K.Thomas@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Certain
public meetings involving CDER from
March 10 through April 30, 2020, are
postponed, cancelled, or modified to
take place remotely due to extenuating
circumstances. The meetings that are
postponed or canceled as part of this
notice are listed in table 1. If a meeting
is rescheduled, information about the
rescheduled meeting will be provided in
the future. The meeting that will no
longer take place in person and instead
take place by webcast only as part of
this notice is listed in table 2.1
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–N–0001, FDA–
2020–N–0255, FDA–2020–N–0256, FDA–
2020–N–0259, FDA–2018–N–4337]
March 10 Through April 30, 2020,
Public Meetings; Postponement,
Cancellation, or Remote Only
AGENCY:
Food and Drug Administration,
HHS.
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1 Up-to-date information about public meetings
involving CDER is available on the internet at
https://www.fda.gov/drugs/news-events-humandrugs/meetings-conferences-workshops-drugs.
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15790
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
TABLE 1—CDER MEETINGS POSTPONED OR CANCELLED
Meeting type
Meeting title
Original meeting
date
Docket No.
Federal Register
citation
Public Meeting ........
Patient-Focused Drug Development for Stimulant Use Disorder.
Patient-Focused Drug Development for Vitiligo
Mar. 10, 2020 ........
FDA–2020–N–0259 .....
Mar. 30, 2020 ........
FDA–2020–N–0255 .....
Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.
Apr. 16, 2020 .........
FDA–2020–N–0001 .....
Apr. 22, 2020 .........
FDA–2018–N–4337 .....
85 FR 8877, Feb. 18,
2020.
85 FR 8004, Feb. 12,
2020.
85 FR 14207, Mar. 11,
2020.
85 FR 6547, Feb. 5,
2020.
Public Meeting ........
Public Meeting ........
Public Meeting ........
TABLE 2—CDER MEETING HELD REMOTELY
Meeting type
Meeting title
Original meeting
date
Docket No.
Public Meeting .........
United States Food and Drug
Administration and Health
Canada Joint Regional Consultation on the International
Council for Harmonisation of
Technical Requirements for
Pharmaceuticals for Human
Use.
Apr. 3, 2020 ...........
FDA–2020–N–
0256.
Dated: March 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05743 Filed 3–18–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3591]
Gerald Tighe: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Gerald
Tighe from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Tighe was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Mr. Tighe
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Mr. Tighe failed to respond. Mr. Tighe’s
failure to request a hearing within the
prescribed timeframe constitutes a
waiver of his right to a hearing
concerning this action.
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SUMMARY:
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This order is applicable March
19, 2020.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, or 240–402–8743.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act. On
July 14, 2017, Mr. Tighe pleaded guilty
to one count of conspiracy to commit
wire fraud, a felony offense, in violation
of 18 U.S.C. 371. On December 19, 2017,
judgment was entered against Mr. Tighe
in the U. S. District Court for the Eastern
District of New York.
The factual basis for this conviction is
as follows: Mr. Tighe was the founder,
sole owner, and president of Med Prep
Consulting, Inc. (Med Prep), a medical
drug repackager located and
incorporated in New Jersey in 1994.
Med Prep manufactured, repackaged,
processed, packed, labeled, held,
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Federal Register citation
Remote information
85 FR 13659,
https://www.fda.gov/drugs/
Mar. 9, 2020.
news-events-human-drugs/
health-canada-and-fda-jointpublic-consultation-international-councilharmonisation-technical-0.
compounded, and distributed various
drug products, including pain
management medications, anesthesia
and operating room drugs, and oncology
and dialysis drugs. As president of Med
Prep, Mr. Tighe was the highest-ranking
corporate official, and he was
responsible for and oversaw all aspects
of its business, including its
manufacturing and quality operations.
Between approximately January 2007
and April 2013, Mr. Tighe knowingly
and intentionally conspired with other
individuals to devise a scheme and
artifice to defraud healthcare providers
and to obtain money and property from
them by means of materially false and
fraudulent pretenses, representations,
and promises, and for the purpose of
executing such scheme and artifice, and
attempting to do so, to transmit and
cause to be transmitted, by means of
wire communication in interstate
commerce, writings, signs, signals,
pictures, and sounds.
Specifically, during this time period,
Mr. Tighe conspired with others to
introduce and introduced, or caused the
introduction of, adulterated and
misbranded drugs into interstate
commerce, all with the intent to defraud
and mislead healthcare providers. The
adulterated drugs Mr. Tighe introduced
or caused to be introduced into
interstate commerce were adulterated
because they were prepared, packed,
and held under insanitary conditions
and because the drugs consisted in
whole or in part of a filthy, putrid, and
decomposed substance. The misbranded
drugs Mr. Tighe introduced or caused to
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]]>Agencies
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15789-15790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05743]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-N-0001, FDA-2020-N-0255, FDA-2020-N-0256, FDA-
2020-N-0259, FDA-2018-N-4337]
March 10 Through April 30, 2020, Public Meetings; Postponement,
Cancellation, or Remote Only
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is announcing that certain
meetings involving the Center for Drug Evaluation and Research (CDER)
from March 10 through April 30, 2020, are postponed, cancelled, or
modified to take place remotely.
DATES: For dates that have been either postponed or cancelled, see
table 1 in the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Kim Thomas, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-2357,
[email protected].
SUPPLEMENTARY INFORMATION: Certain public meetings involving CDER from
March 10 through April 30, 2020, are postponed, cancelled, or modified
to take place remotely due to extenuating circumstances. The meetings
that are postponed or canceled as part of this notice are listed in
table 1. If a meeting is rescheduled, information about the rescheduled
meeting will be provided in the future. The meeting that will no longer
take place in person and instead take place by webcast only as part of
this notice is listed in table 2.\1\
---------------------------------------------------------------------------
\1\ Up-to-date information about public meetings involving CDER
is available on the internet at https://www.fda.gov/drugs/news-events-human-drugs/meetings-conferences-workshops-drugs.
[[Page 15790]]
Table 1--CDER Meetings Postponed or Cancelled
----------------------------------------------------------------------------------------------------------------
Federal Register
Meeting type Meeting title Original meeting date Docket No. citation
----------------------------------------------------------------------------------------------------------------
Public Meeting............ Patient-Focused Drug Mar. 10, 2020............ FDA-2020-N-0259. 85 FR 8877, Feb.
Development for 18, 2020.
Stimulant Use
Disorder.
Public Meeting............ Patient-Focused Drug Mar. 30, 2020............ FDA-2020-N-0255. 85 FR 8004, Feb.
Development for 12, 2020.
Vitiligo.
Public Meeting............ Scientific and Apr. 16, 2020............ FDA-2020-N-0001. 85 FR 14207,
Ethical Mar. 11, 2020.
Considerations for
the Inclusion of
Pregnant Women in
Clinical Trials.
Public Meeting............ Prescription Drug Apr. 22, 2020............ FDA-2018-N-4337. 85 FR 6547, Feb.
User Fee Act of 5, 2020.
2017; Electronic
Submissions and Data
Standards.
----------------------------------------------------------------------------------------------------------------
Table 2--CDER Meeting Held Remotely
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Register
Meeting type Meeting title Original meeting date Docket No. citation Remote information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public Meeting.............. United States Food and Apr. 3, 2020................ FDA-2020-N-0256.... 85 FR 13659, Mar. https://www.fda.gov/
Drug Administration and 9, 2020. drugs/news-events-human-
Health Canada Joint drugs/health-canada-and-
Regional Consultation fda-joint-public-
on the International consultation-
Council for international-council-
Harmonisation of harmonisation-technical-
Technical Requirements 0.
for Pharmaceuticals for
Human Use.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: March 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05743 Filed 3-18-20; 8:45 am]
BILLING CODE 4164-01-P
