81 FR 34348 - Clinical Trial Design Considerations for Malaria Drug Development; Notice of Public Workshop; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34348-34349 | |
| FR Document | 2016-12654 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34348-34349] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://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
![34348 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
(levothyroxine sodium) tablets, 0.025 FDA may not approve an ANDA that suggesting that this drug product was
milligram (mg), 0.05 mg, 0.075 mg, does not refer to a listed drug. withdrawn for reasons of safety or
0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, LEVOTHROID (levothyroxine effectiveness. We have carefully
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and sodium) tablets, 0.025 mg, 0.05 mg, reviewed our files for records
0.3 mg, were not withdrawn from sale 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, concerning the withdrawal of
for reasons of safety or effectiveness. 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 LEVOTHROID (levothyroxine sodium)
This determination will allow FDA to mg, and 0.3 mg, are the subject of NDA tablets, 0.025 mg, 0.05 mg, 0.075 mg,
approve abbreviated new drug 021116, held by Lloyd Inc., and initially 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
applications (ANDAs) for LEVOTHROID approved on October 24, 2002. 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
(levothyroxine sodium) tablets, 0.025 LEVOTHROID is used for the following 0.3 mg, from sale. We have also
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 indications: independently evaluated relevant
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 • Hypothyroidism—As replacement literature and data for possible
mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all or supplemental therapy in congenital postmarketing adverse events. We have
other legal and regulatory requirements or acquired hypothyroidism of any found no information that would
are met. etiology, except transient indicate that this drug product was
FOR FURTHER INFORMATION CONTACT:
hypothyroidism during the recovery withdrawn from sale for reasons of
phase of subacute thyroiditis. Specific safety or effectiveness.
Reena Raman, Center for Drug
indications include: Primary (thyroidal), Accordingly, the Agency will
Evaluation and Research, Food and
secondary (pituitary), and tertiary continue to list LEVOTHROID
Drug Administration, 10903 New
(hypothalamic) hypothyroidism and (levothyroxine sodium) tablets, 0.025
Hampshire Ave., Bldg. 51, Rm. 6284,
subclinical hypothyroidism. Primary mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
Silver Spring, MD 20993–0002, 301–
hypothyroidism may result from mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
796–7577.
functional deficiency, primary atrophy, mg, 0.1 mg, 0.2 mg, and 0.3 mg, in the
SUPPLEMENTARY INFORMATION: In 1984, partial or total congenital absence of the
Congress enacted the Drug Price ‘‘Discontinued Drug Product List’’
thyroid gland, or from the effects of section of the Orange Book. The
Competition and Patent Term surgery, radiation, or drugs, with or
Restoration Act of 1984 (Pub. L. 98–417) ‘‘Discontinued Drug Product List’’
without the presence of goiter. delineates, among other items, drug
(the 1984 amendments), which • Pituitary Thyrotropine-Stimulating
authorized the approval of duplicate products that have been discontinued
Hormone Suppression—In the treatment
versions of drug products under an from marketing for reasons other than
or prevention of various types of
ANDA procedure. ANDA applicants safety or effectiveness. ANDAs that refer
euthyroid goiters, including thyroid
must, with certain exceptions, show that to this drug product may be approved
nodules, subacute or chronic
the drug for which they are seeking by the Agency as long as they meet all
lymphocytic thyroiditis (Hashimoto’s
approval contains the same active other legal and regulatory requirements
thyroiditis), multinodular goiter, and as
ingredient in the same strength and for the approval of ANDAs. If FDA
an adjunct to surgery and radioiodine
dosage form as the ‘‘listed drug,’’ which therapy in the management of determines that labeling for this drug
is a version of the drug that was thyrotropin-dependent well- product should be revised to meet
previously approved. ANDA applicants differentiated thyroid cancer. current standards, the Agency will
do not have to repeat the extensive LEVOTHROID (levothyroxine advise ANDA applicants to submit such
clinical testing otherwise necessary to sodium) tablets, 0.025 mg, 0.05 mg, labeling.
gain approval of a new drug application 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, Dated: May 24, 2016.
(NDA). 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 Leslie Kux,
The 1984 amendments include what mg, and 0.3 mg are currently listed in Associate Commissioner for Policy.
is now section 505(j)(7) of the Federal the ‘‘Discontinued Drug Product List’’ [FR Doc. 2016–12655 Filed 5–27–16; 8:45 am]
Food, Drug, and Cosmetic Act (21 U.S.C. section of the Orange Book. BILLING CODE 4164–01–P
355(j)(7)), which requires FDA to Lachman Consultant Services, Inc.,
publish a list of all approved drugs. submitted a citizen petition dated
FDA publishes this list as part of the February 4, 2015 (Docket No. FDA– DEPARTMENT OF HEALTH AND
‘‘Approved Drug Products With 2015–P–0403), under 21 CFR 10.30, HUMAN SERVICES
Therapeutic Equivalence Evaluations,’’ requesting that the Agency determine
which is known generally as the whether LEVOTHROID (levothyroxine Food and Drug Administration
‘‘Orange Book.’’ Under FDA regulations, sodium) tablets, 0.025 mg, 0.05 mg,
drugs are removed from the list if the [Docket No. FDA–2016–N–0001]
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
Agency withdraws or suspends 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 Clinical Trial Design Considerations
approval of the drug’s NDA or ANDA mg, and 0.3 mg, were withdrawn from for Malaria Drug Development; Notice
for reasons of safety or effectiveness or sale for reasons of safety or of Public Workshop; Correction
if FDA determines that the listed drug effectiveness.
was withdrawn from sale for reasons of After considering the citizen petition AGENCY: Food and Drug Administration,
safety or effectiveness (21 CFR 314.162). and reviewing Agency records and HHS.
A person may petition the Agency to based on the information we have at this ACTION: Notice; correction.
determine, or the Agency may time, FDA has determined under
determine on its own initiative, whether § 314.161 that LEVOTHROID SUMMARY: The Food and Drug
sradovich on DSK3TPTVN1PROD with NOTICES
a listed drug was withdrawn from sale (levothyroxine sodium) tablets, 0.025 Administration (FDA) is correcting a
for reasons of safety or effectiveness. mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 notice that appeared in the Federal
This determination may be made at any mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 Register of Tuesday, May 10, 2016 (81
time after the drug has been withdrawn mg, 0.1 mg, 0.2 mg, and 0.3 mg, were FR 28876). The document announced a
from sale, but must be made prior to not withdrawn for reasons of safety or public workshop entitled ‘‘Clinical Trial
approving an ANDA that refers to the effectiveness. The petitioner has Design Considerations for Malaria Drug
listed drug (§ 314.161 (21 CFR 314.161)). identified no data or other information Development.’’ The document was
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![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34349
published with the incorrect title and ACTION: Notice. system. It is responsible for providing
incorrect Internet address in the leadership on global health matters,
Transcripts section. This document SUMMARY: The Food and Drug shaping the health research agenda,
corrects those errors. Administration (FDA) announces its setting norms and standards,
FOR FURTHER INFORMATION CONTACT: Lori
intention to accept and consider a single articulating evidence-based policy
Benner and/or Jessica Barnes, Center for source application for award of a options, providing technical support to
Drug Evaluation and Research, Food cooperative agreement to the World countries, and monitoring and assessing
and Drug Administration, 10903 New Health Organization (WHO) in support health trends. WHO assists countries in
Hampshire Ave., Bldg. 22, Rm. 6221, of collaboration in regulatory systems building capacity to increase and
Silver Spring, MD 20993–0002, 301– strengthening, development of norms sustain access to medical products to
796–1300. and standards, and innovative research prevent, detect, and treat communicable
to advance global access to safe and diseases, including reducing vaccine-
SUPPLEMENTARY INFORMATION: In FR Doc.
effective biological products that meet preventable diseases. WHO also
2016–10913, appearing on page 28876 international standards. The goal of
in the Federal Register of Tuesday, May coordinates efforts to respond to public
FDA’s Center for Biologics Evaluation health emergencies by monitoring the
10, 2016, the following corrections are and Research (FDA/CBER) is to enhance
made: health situation, undertaking risk
technical collaboration and cooperation assessments, identifying priorities, and
1. On page 28876, in the first column,
between the FDA, WHO, and its providing technical guidance and other
the title is corrected to read ‘‘Clinical
member states to facilitate strengthening forms of support to countries and
Trial Design Considerations for Malaria
regulatory capacity and support product regions.
Drug Development.’’
2. On page 28876, in the second development and standardization Providing adequate regulatory
column, the Transcripts section is activities to increase access to safe and oversight throughout the product life
corrected to read ‘‘Please be advised that effective biologicals globally. cycle (pre- and post-licensure) is
as soon as a transcript is available, it DATES: The application due date is July essential for assuring the safety, purity,
5, 2016. and potency of vaccines and other
will be accessible at http://
ADDRESSES: Submit electronic
biologicals. However, this is a major
www.regulations.gov. It may be viewed
applications to http://www.grants.gov. challenge for many National Regulatory
at the Division of Dockets Management
For more information, see section III of Authorities (NRAs) confronted by a
(HFA–305), Food and Drug
the SUPPLEMENTARY INFORMATION section steadily increasing number of novel
Administration, 5630 Fishers Lane,
of this notice. products, complex quality concerns,
Rm.1061, Rockville, MD. A transcript
new regulatory issues arising from rapid
will also be available in either hard FOR FURTHER INFORMATION CONTACT: technical and technological advances,
copy or on CD–ROM, after submission Gopa Raychaudhuri, CBER Liaison to and emerging infectious diseases (e.g.,
of a Freedom of Information request. WHO, Office of the Director, Food and pandemic influenza, Middle East
Written requests are to be sent to Drug Administration, 10903 New Respiratory Syndrome, Ebola, Zika).
Division of Freedom of Information Hampshire Ave., Bldg. 71, Rm. 7250, WHO has an important role in
(HFI–35), Office of Management Silver Spring, MD 20993, 240–402– strengthening regulatory systems and
Programs, Food and Drug 8000, gopa.raychaudhuri@fda.hhs.gov; other supportive activities to increase
Administration, 5600 Fishers Lane, Rm. or Leslie Haynes, Foreign Regulatory access to high quality, safe, and effective
6–30, Rockville, MD 20857. Transcripts Capacity Building Coordinator, biological products especially in low-
will also be available on the Internet at International Affairs, Office of the and-middle-income countries. It is the
http://www.fda.gov/Drugs/NewsEvents/ Director, Food and Drug only organization with the mandate,
ucm490084.htm approximately 45 days Administration, 10903 New Hampshire access to technical expertise, and broad
after the workshop. Ave., Bldg. 71, Rm. 7222, Silver Spring, reach to meet the research objectives.
If you need special accommodations MD 20993, 240–402–8074, FDA/CBER has been a leader and
because of a disability, please contact leslie.haynes@fda.hhs.gov; or Bryce active participant in the global
Jessica Barnes or Lori Benner (see Jones, Grants Management Specialist, community to improve human health in
Contact Person) at least 7 days in Division of Acquisition and Grants, the world’s populations over many
advance.’’ Office of Acquisitions and Grants years. Its international engagements
Dated: May 24, 2016. Services, Food and Drug have been informed by the knowledge
Leslie Kux, Administration, 5630 Fishers Lane, Rm. that protection of global public health
Associate Commissioner for Policy. 2026, Rockville, MD 20857, 240–402– against infectious disease threats
[FR Doc. 2016–12654 Filed 5–27–16; 8:45 am]
2111, Bryce.Jones@fda.hhs.gov. translates into protection of public
For more information on this funding health in the United States. FDA,
BILLING CODE 4164–01–P
opportunity announcement (FOA) and through CBER, has longstanding
to obtain detailed requirements, please collaborations with WHO in the area of
DEPARTMENT OF HEALTH AND refer to the full FOA located at http:// biologicals (vaccines, blood and blood
HUMAN SERVICES www.grants.gov. Search by Funding products, relevant in vitro diagnostics,
Opportunity Number: RFA–FD–16–044. and cell and tissue therapies).
Food and Drug Administration SUPPLEMENTARY INFORMATION: FDA/CBER has been a Pan American
Health Organization/WHO Collaborating
[Docket No. FDA–2016–N–1269] I. Funding Opportunity Description Center for Biological Standardization
sradovich on DSK3TPTVN1PROD with NOTICES
RFA–FD–16–044 since 1998 with the current
Collaboration in Regulatory Systems
93.103 commitment running until 2020 and
Strengthening and Standardization
expectation of future extensions. As a
Activities To Increase Access to Safe A. Background WHO Collaborating Center for
and Effective Biological Products
WHO is the directing and Biological Standardization, CBER has
AGENCY: Food and Drug Administration, coordinating authority on international provided scientific and technical
HHS. health within the United Nations’ (UN) support to WHO for development of
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Document Created: 2016-05-28 03:57:41
Document Modified: 2016-05-28 03:57:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; correction. | |
| 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. | |
| FR Citation | 81 FR 34348 |
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