Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Public Meeting, 51323-51324 [2023-16544]
Download as PDF
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, 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access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Sophia Park, Division of User Fee
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–7900,
CDERCollections@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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 FDA’s guidance entitled
‘‘Prescription Drug User Fee Act
Waivers, Reductions, and Refunds for
Drug and Biological Products’’
associated with requesting waivers of
user fees (including PEPFAR waivers)
has been approved under OMB control
number 0910–0693. The collection of
information in completing and
submitting FDA Form FDA 3397
(Prescription Drug User Fee Coversheet)
has been approved under OMB control
number 0910–0297. The collection of
information in 21 CFR part 314 for
submission of a new drug application
has been approved under OMB control
number 0910–0001.
I. Background
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘PDUFA Waivers, Reductions, and
Refunds for Fixed-Combinations and
Single-Entity Versions of Previously
Approved Antiretrovirals under
PEPFAR.’’ This draft guidance is
proposed as a revision of the guidance
for industry entitled ‘‘User Fee Waivers
for FDC and Co-Packaged HIV Drugs for
PEPFAR,’’ issued February 2007. The
draft guidance describes circumstances
under which an applicant may be
eligible for a barrier-to-innovation
waiver under PDUFA for certain NDAs
for SE ARV and FC ARV drug products
for the treatment of HIV–1. When final,
this guidance will supersede the
guidance for industry entitled ‘‘User Fee
Waivers for FDC and Co-Packaged HIV
Drugs for PEPFAR,’’ issued February
2007.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘PDUFA Waivers, Reductions, and
Refunds for Fixed-Combinations and
Single-Entity Versions of Previously
Approved Antiretrovirals under
PEPFAR.’’ 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
VerDate Sep<11>2014
17:35 Aug 02, 2023
Jkt 259001
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16560 Filed 8–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0001]
Mitigating Clinical Study Disruptions
During Disasters and Public Health
Emergencies; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public meeting
entitled ‘‘Mitigating Clinical Study
Disruptions During Disasters and Public
Health Emergencies.’’ This public
meeting will satisfy the mandate of the
Food and Drug Omnibus Reform Act of
2022 (FDORA) to convene a public
meeting on clinical study flexibilities
initiated in response to the COVID–19
pandemic. The public meeting will be
convened and supported by a
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
51323
cooperative agreement between FDA
and the Clinical Trials Transformation
Initiative (CTTI) to bring the clinical
research community together to discuss
a variety of topics related to mitigating
disruptions of clinical studies of
medical products during disasters and
public health emergencies (PHEs). The
meeting format will include
presentations and panel discussions.
DATES: The public meeting will be held
virtually on October 18 and 19, 2023,
from 10 a.m. to 1:30 p.m. Eastern Time.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public meeting will be
held virtually using the Zoom platform.
The link for the public meeting will be
sent to registrants upon registration.
FOR FURTHER INFORMATION CONTACT: Dat
Doan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3334, Silver Spring,
MD 20993, 240–402–8926, Dat.Doan@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting satisfies FDA’s
mandate under section 3605 of FDORA
to convene a public meeting, not later
than 180 days after the date when the
COVID–19 emergency period ends, to
discuss the recommendations provided
by FDA during the COVID–19
emergency period to mitigate disruption
of clinical studies. Among other things,
the public meeting will include
discussion about strategies for
mitigating disruptions of clinical studies
of medical products during disasters
and PHEs.
II. Topics for Discussion at the Public
Meeting
Topics for discussion during this
meeting include:
1. The recommendations provided by
FDA during the COVID–19
emergency period to mitigate
disruption of clinical studies,
including recommendations
detailed in the guidance for
industry, investigators, and
institutional review boards entitled
‘‘Conduct of Clinical Trials of
Medical Products During the
COVID–19 Public Health
Emergency 1’’ (March 2020, updated
August 2021)
2. The actions sponsors took to utilize
such recommendations and the
1 Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/fdaguidance-conduct-clinical-trials-medical-productsduring-covid-19-public-health-emergency.
E:\FR\FM\03AUN1.SGM
03AUN1
51324
Federal Register / Vol. 88, No. 148 / Thursday, August 3, 2023 / Notices
frequency at which such
recommendations were utilized
3. The characteristics of the sponsors,
studies, and patient populations
impacted by such recommendations
4. Consideration of how
recommendations intended to
mitigate disruption of clinical
studies during the COVID–19
emergency period, including any
recommendations to consider
decentralized clinical studies when
appropriate, may have affected
access to clinical studies for certain
patient populations, especially
underrepresented racial and ethnic
minorities
5. Recommendations for incorporating
certain clinical study disruption
mitigation recommendations into
current or additional guidance to
improve clinical study access and
enrollment of diverse patient
populations
6. Strategies for advanced planning to
mitigate disruption of clinical
studies during future disasters and
PHEs
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: duke.zoom.us/meeting/register/
tJAvcO-oqD4vE9Ov1VvA3SoItVhL7Rhg66T. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free, and persons
interested in attending this public
meeting must register to receive a link
to the meeting. Registrants will receive
a confirmation email after they register.
If you need special accommodations
due to a disability, please contact
Summer.Starling@duke.edu no later
than October 4, 2023. Please note,
closed captioning will be available
automatically.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16544 Filed 8–2–23; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:35 Aug 02, 2023
Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–2339]
Determination That K–TAB (Potassium
Chloride) Extended-Release Tablets,
10 Milliequivalents and 20
Milliequivalents, Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that K–TAB (potassium
chloride) extended-release tablets, 10
milliequivalents and 20
milliequivalents, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
potassium chloride extended-release
tablets, 10 milliequivalents (meqs) and
20 meqs, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Veniqua Stewart, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002, 301–
796–3627, veniqua.stewart@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
K–TAB (potassium chloride)
extended-release tablets, 10 meqs and
20 meqs, are two of the subjects of NDA
018279, held by AbbVie Inc. The NDA
was initially approved on June 9, 1980.
K–TAB is indicated for the treatment
and prophylaxis of hypokalemia with or
without metabolic alkalosis in patients
for whom dietary management with
potassium-rich foods or diuretic dose
reduction is insufficient.
The K–TAB (potassium chloride)
extended-release tablets, 10 meqs and
20 meqs, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Granules India Ltd. submitted a
citizen petition dated June 8, 2023
(Docket No. FDA–2023–P–2339), under
21 CFR 10.30, requesting that the
Agency determine whether K–TAB
(potassium chloride) extended-release
tablets, 10 meqs and 20 meqs, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that K–TAB (potassium
chloride) extended-release tablets, 10
meqs and 20 meqs, were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that K–
TAB (potassium chloride) extendedrelease tablets, 10 meqs and 20 meqs,
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of K–TAB
(potassium chloride) extended-release
tablets, 10 meqs and 20 meqs, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list K–TAB (potassium
E:\FR\FM\03AUN1.SGM
03AUN1
Agencies
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51323-51324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16544]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0001]
Mitigating Clinical Study Disruptions During Disasters and Public
Health Emergencies; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``Mitigating Clinical Study
Disruptions During Disasters and Public Health Emergencies.'' This
public meeting will satisfy the mandate of the Food and Drug Omnibus
Reform Act of 2022 (FDORA) to convene a public meeting on clinical
study flexibilities initiated in response to the COVID-19 pandemic. The
public meeting will be convened and supported by a cooperative
agreement between FDA and the Clinical Trials Transformation Initiative
(CTTI) to bring the clinical research community together to discuss a
variety of topics related to mitigating disruptions of clinical studies
of medical products during disasters and public health emergencies
(PHEs). The meeting format will include presentations and panel
discussions.
DATES: The public meeting will be held virtually on October 18 and 19,
2023, from 10 a.m. to 1:30 p.m. Eastern Time. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held virtually using the Zoom
platform. The link for the public meeting will be sent to registrants
upon registration.
FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting satisfies FDA's mandate under section 3605 of
FDORA to convene a public meeting, not later than 180 days after the
date when the COVID-19 emergency period ends, to discuss the
recommendations provided by FDA during the COVID-19 emergency period to
mitigate disruption of clinical studies. Among other things, the public
meeting will include discussion about strategies for mitigating
disruptions of clinical studies of medical products during disasters
and PHEs.
II. Topics for Discussion at the Public Meeting
Topics for discussion during this meeting include:
1. The recommendations provided by FDA during the COVID-19 emergency
period to mitigate disruption of clinical studies, including
recommendations detailed in the guidance for industry, investigators,
and institutional review boards entitled ``Conduct of Clinical Trials
of Medical Products During the COVID-19 Public Health Emergency \1\''
(March 2020, updated August 2021)
---------------------------------------------------------------------------
\1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency.
---------------------------------------------------------------------------
2. The actions sponsors took to utilize such recommendations and the
[[Page 51324]]
frequency at which such recommendations were utilized
3. The characteristics of the sponsors, studies, and patient
populations impacted by such recommendations
4. Consideration of how recommendations intended to mitigate disruption
of clinical studies during the COVID-19 emergency period, including any
recommendations to consider decentralized clinical studies when
appropriate, may have affected access to clinical studies for certain
patient populations, especially underrepresented racial and ethnic
minorities
5. Recommendations for incorporating certain clinical study disruption
mitigation recommendations into current or additional guidance to
improve clinical study access and enrollment of diverse patient
populations
6. Strategies for advanced planning to mitigate disruption of clinical
studies during future disasters and PHEs
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: duke.zoom.us/meeting/register/tJAvcO-oqD4vE9Ov1Vv-
A3SoItVhL7Rhg66T. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone.
Registration is free, and persons interested in attending this
public meeting must register to receive a link to the meeting.
Registrants will receive a confirmation email after they register.
If you need special accommodations due to a disability, please
contact [email protected] no later than October 4, 2023. Please
note, closed captioning will be available automatically.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16544 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P