Clinical Trial Design Considerations for Malaria Drug Development; Notice of Public Workshop; Correction, 34348-34349 [2016-12654]
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sradovich on DSK3TPTVN1PROD with NOTICES
34348
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
(levothyroxine sodium) tablets, 0.025
milligram (mg), 0.05 mg, 0.075 mg,
0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for LEVOTHROID
(levothyroxine sodium) tablets, 0.025
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Reena Raman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6284,
Silver Spring, MD 20993–0002, 301–
796–7577.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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 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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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)).
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20:07 May 27, 2016
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FDA may not approve an ANDA that
does not refer to a listed drug.
LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg,
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2
mg, and 0.3 mg, are the subject of NDA
021116, held by Lloyd Inc., and initially
approved on October 24, 2002.
LEVOTHROID is used for the following
indications:
• Hypothyroidism—As replacement
or supplemental therapy in congenital
or acquired hypothyroidism of any
etiology, except transient
hypothyroidism during the recovery
phase of subacute thyroiditis. Specific
indications include: Primary (thyroidal),
secondary (pituitary), and tertiary
(hypothalamic) hypothyroidism and
subclinical hypothyroidism. Primary
hypothyroidism may result from
functional deficiency, primary atrophy,
partial or total congenital absence of the
thyroid gland, or from the effects of
surgery, radiation, or drugs, with or
without the presence of goiter.
• Pituitary Thyrotropine-Stimulating
Hormone Suppression—In the treatment
or prevention of various types of
euthyroid goiters, including thyroid
nodules, subacute or chronic
lymphocytic thyroiditis (Hashimoto’s
thyroiditis), multinodular goiter, and as
an adjunct to surgery and radioiodine
therapy in the management of
thyrotropin-dependent welldifferentiated thyroid cancer.
LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg,
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2
mg, and 0.3 mg are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated
February 4, 2015 (Docket No. FDA–
2015–P–0403), under 21 CFR 10.30,
requesting that the Agency determine
whether LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg,
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2
mg, and 0.3 mg, 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 LEVOTHROID
(levothyroxine sodium) tablets, 0.025
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
mg, 0.1 mg, 0.2 mg, and 0.3 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
PO 00000
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suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
LEVOTHROID (levothyroxine sodium)
tablets, 0.025 mg, 0.05 mg, 0.075 mg,
0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list LEVOTHROID
(levothyroxine sodium) tablets, 0.025
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
mg, 0.1 mg, 0.2 mg, and 0.3 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to this drug product may be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12655 Filed 5–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Clinical Trial Design Considerations
for Malaria Drug Development; Notice
of Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, May 10, 2016 (81
FR 28876). The document announced a
public workshop entitled ‘‘Clinical Trial
Design Considerations for Malaria Drug
Development.’’ The document was
SUMMARY:
E:\FR\FM\31MYN1.SGM
31MYN1
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
published with the incorrect title and
incorrect Internet address in the
Transcripts section. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT: Lori
Benner and/or Jessica Barnes, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6221,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION: In FR Doc.
2016–10913, appearing on page 28876
in the Federal Register of Tuesday, May
10, 2016, the following corrections are
made:
1. On page 28876, in the first column,
the title is corrected to read ‘‘Clinical
Trial Design Considerations for Malaria
Drug Development.’’
2. On page 28876, in the second
column, the Transcripts section is
corrected to read ‘‘Please be advised that
as soon as a transcript is available, it
will be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane,
Rm.1061, Rockville, MD. A transcript
will also be available in either hard
copy or on CD–ROM, after submission
of a Freedom of Information request.
Written requests are to be sent to
Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, Rm.
6–30, Rockville, MD 20857. Transcripts
will also be available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm490084.htm approximately 45 days
after the workshop.
If you need special accommodations
because of a disability, please contact
Jessica Barnes or Lori Benner (see
Contact Person) at least 7 days in
advance.’’
ACTION:
Notice.
Food and Drug Administration
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
source application for award of a
cooperative agreement to the World
Health Organization (WHO) in support
of collaboration in regulatory systems
strengthening, development of norms
and standards, and innovative research
to advance global access to safe and
effective biological products that meet
international standards. The goal of
FDA’s Center for Biologics Evaluation
and Research (FDA/CBER) is to enhance
technical collaboration and cooperation
between the FDA, WHO, and its
member states to facilitate strengthening
regulatory capacity and support product
development and standardization
activities to increase access to safe and
effective biologicals globally.
DATES: The application due date is July
5, 2016.
ADDRESSES: Submit electronic
applications to https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Gopa Raychaudhuri, CBER Liaison to
WHO, Office of the Director, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7250,
Silver Spring, MD 20993, 240–402–
8000, gopa.raychaudhuri@fda.hhs.gov;
or Leslie Haynes, Foreign Regulatory
Capacity Building Coordinator,
International Affairs, Office of the
Director, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7222, Silver Spring,
MD 20993, 240–402–8074,
leslie.haynes@fda.hhs.gov; or Bryce
Jones, Grants Management Specialist,
Division of Acquisition and Grants,
Office of Acquisitions and Grants
Services, Food and Drug
Administration, 5630 Fishers Lane, Rm.
2026, Rockville, MD 20857, 240–402–
2111, Bryce.Jones@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.grants.gov. Search by Funding
Opportunity Number: RFA–FD–16–044.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2016–N–1269]
I. Funding Opportunity Description
Collaboration in Regulatory Systems
Strengthening and Standardization
Activities To Increase Access to Safe
and Effective Biological Products
RFA–FD–16–044
93.103
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12654 Filed 5–27–16; 8:45 am]
BILLING CODE 4164–01–P
sradovich on DSK3TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
20:07 May 27, 2016
Jkt 238001
SUMMARY:
A. Background
WHO is the directing and
coordinating authority on international
health within the United Nations’ (UN)
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34349
system. It is responsible for providing
leadership on global health matters,
shaping the health research agenda,
setting norms and standards,
articulating evidence-based policy
options, providing technical support to
countries, and monitoring and assessing
health trends. WHO assists countries in
building capacity to increase and
sustain access to medical products to
prevent, detect, and treat communicable
diseases, including reducing vaccinepreventable diseases. WHO also
coordinates efforts to respond to public
health emergencies by monitoring the
health situation, undertaking risk
assessments, identifying priorities, and
providing technical guidance and other
forms of support to countries and
regions.
Providing adequate regulatory
oversight throughout the product life
cycle (pre- and post-licensure) is
essential for assuring the safety, purity,
and potency of vaccines and other
biologicals. However, this is a major
challenge for many National Regulatory
Authorities (NRAs) confronted by a
steadily increasing number of novel
products, complex quality concerns,
new regulatory issues arising from rapid
technical and technological advances,
and emerging infectious diseases (e.g.,
pandemic influenza, Middle East
Respiratory Syndrome, Ebola, Zika).
WHO has an important role in
strengthening regulatory systems and
other supportive activities to increase
access to high quality, safe, and effective
biological products especially in lowand-middle-income countries. It is the
only organization with the mandate,
access to technical expertise, and broad
reach to meet the research objectives.
FDA/CBER has been a leader and
active participant in the global
community to improve human health in
the world’s populations over many
years. Its international engagements
have been informed by the knowledge
that protection of global public health
against infectious disease threats
translates into protection of public
health in the United States. FDA,
through CBER, has longstanding
collaborations with WHO in the area of
biologicals (vaccines, blood and blood
products, relevant in vitro diagnostics,
and cell and tissue therapies).
FDA/CBER has been a Pan American
Health Organization/WHO Collaborating
Center for Biological Standardization
since 1998 with the current
commitment running until 2020 and
expectation of future extensions. As a
WHO Collaborating Center for
Biological Standardization, CBER has
provided scientific and technical
support to WHO for development of
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34348-34349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12654]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Clinical Trial Design Considerations for Malaria Drug
Development; Notice of Public Workshop; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Tuesday, May 10, 2016 (81 FR
28876). The document announced a public workshop entitled ``Clinical
Trial Design Considerations for Malaria Drug Development.'' The
document was
[[Page 34349]]
published with the incorrect title and incorrect Internet address in
the Transcripts section. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002, 301-796-1300.
SUPPLEMENTARY INFORMATION: In FR Doc. 2016-10913, appearing on page
28876 in the Federal Register of Tuesday, May 10, 2016, the following
corrections are made:
1. On page 28876, in the first column, the title is corrected to
read ``Clinical Trial Design Considerations for Malaria Drug
Development.''
2. On page 28876, in the second column, the Transcripts section is
corrected to read ``Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD. A
transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, Rm. 6-30, Rockville, MD 20857. Transcripts will also be available
on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm490084.htm
approximately 45 days after the workshop.
If you need special accommodations because of a disability, please
contact Jessica Barnes or Lori Benner (see Contact Person) at least 7
days in advance.''
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12654 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P
