Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications, 28856-28857 [2018-13293]
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Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Compounding outsourcing facility
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submission of adverse event reports including copy of labeling and other information as described in the guidance ..................................................................................
55
1
55
1.1
61
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of recordkeeping
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Records of adverse events, including records of efforts to
obtain the data elements for each adverse event report
55
1
55
16
880
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the
information collection and we have
retained the currently approved burden
estimate. Based on our review of Agency
data, we estimate that annually 55
outsourcing facilities (‘‘Number of
Respondents’’ and ‘‘Total Annual
Responses’’ in table 1) will submit
adverse event reports to FDA as
specified in the guidance and that
preparing and submitting this
information will take approximately 1.1
hours per registrant (‘‘Average Burden
per Response’’ in table 1). Likewise, we
estimate that annually 55 outsourcing
facilities (‘‘Number of Recordkeepers’’
in table 2) will maintain records of
adverse events as specified in the
guidance and that preparing and
maintaining the records will take
approximately 16 hours per registrant
(‘‘Average Burden per Recordkeeping’’
in table 2).
Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
longer marketed and requested that the
approval of the applications be
withdrawn.
[FR Doc. 2018–13294 Filed 6–20–18; 8:45 am]
DATES:
BILLING CODE 4164–01–P
Approval is withdrawn as of July
23, 2018.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2194]
Novartis Pharmaceuticals Corporation,
et al.; Withdrawal of Approval of Five
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of five new drug
applications (NDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
SUMMARY:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 020831 ......
Foradil Aerolizer (formoterol fumarate) Powder, 0.012 milligram (mg)/inhalation.
Axiron (testosterone) Transdermal Metered Solution, 30 mg/
1.5 milliliter (mL) actuation.
Rocephin (ceftriaxone sodium) for Injection, equivalent to
(EQ) 10 gram (g) base/vial, EQ 250 mg base/vial (IV/IM),
EQ 500 mg base/vial (IV/IM), EQ 1 g base/vial (IV/IM), EQ
2 g base/vial (IV/IM), EQ 500 mg base/vial, N/A; N/A, 1%
(Rocephin kit), EQ 1 g base/vial, N/A; N/A, 1% (Rocephin
kit).
Rocephin (ceftriaxone sodium) with Dextrose in Plastic Container Injection, EQ 10 mg base/mL, EQ 20 mg base/mL,
and EQ 40 mg base/mL.
Testosterone Gel, 25 mg/2.5 g packet, 50 mg/5 g packet ......
Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936.
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Hoffmann-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
NDA 022504 ......
amozie on DSK3GDR082PROD with NOTICES1
NDA 050585 ......
NDA 050624 ......
NDA 202763 ......
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Do.
ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN
56623.
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Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 23, 2018.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on July 23, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13293 Filed 6–20–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2018–0009; OMB No.
1660—NEW]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request; Transcript
Request Form
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
The Federal Emergency
Management Agency (FEMA) will
submit the information collection
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
will describe the nature of the
information collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
the actual data collection instruments
FEMA will use.
DATES: Comments must be submitted on
or before July 23, 2018.
ADDRESSES: Submit written comments
on the proposed information collection
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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electronic mail to dhsdeskofficer@
omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Information
Management Division, 500 C Street SW,
Washington, DC 20472, email address
FEMA-Information-CollectionsManagement@fema.dhs.gov or Clarence
(Smiley) White, Chief, Operations and
Support Branch, United States Fire
Administration, 301–447–1055 or by
email at Smiley.White@fema.dhs.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection
previously published in the Federal
Register on February 22, 2018 at 83 FR
7752 with a 60 day public comment
period. FEMA received two anonymous
public comments that were not relevant
to the information collection. The
purpose of this notice is to notify the
public that FEMA will submit the
information collection abstracted below
to the Office of Management and Budget
for review and clearance.
Collection of Information
Title: Transcript Request Form.
Type of Information Collection: New
information collection.
OMB Number: 1660—NEW.
Form Titles and Numbers: FEMA
Form 064–0–0–12, Transcript Request
Form.
Abstract: FEMA provides training to
advance the professional development
of personnel engaged in fire prevention
and control and emergency management
activities through its Center for
Domestic Preparedness (CDP),
Emergency Management Institute (EMI),
National Fire Academy (NFA), National
Training and Education Division,
National Domestic Preparedness
Consortium, and Rural Domestic
Preparedness Consortium. FEMA
collects information from students who
have completed courses at the National
Fire Academy (NFA) and the Emergency
Management Institute (EMI) for the
purpose of fulfilling the student’s
request to provide a copy of their
transcript for their personal records
and/or for transmittal to an institution
of higher education that delivers
training and education also in support
of the FEMA mission.
Affected Public: Individuals or
households; Business or other for-profit;
Not-for-profit institutions; State, Local
or Tribal Government.
Estimated Number of Respondents:
4,500.
Estimated Number of Responses:
4,500.
Estimated Total Annual Burden
Hours: 225 hours.
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28857
Estimated Total Annual Respondent
Cost: $7,978.50.
Estimated Respondents’ Operation
and Maintenance Costs: $0.
Estimated Respondents’ Capital and
Start-Up Costs: $0.
Estimated Total Annual Cost to the
Federal Government: $28,899.24.
Comments
Comments may be submitted as
indicated in the ADDRESSES caption
above. Comments are solicited to (a)
evaluate whether the proposed data
collection is necessary for the proper
performance of the agency, including
whether the information shall have
practical utility; (b) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Rachel Frier,
Records Management Branch Chief, Office
of the Chief Administrative Officer, Mission
Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2018–13291 Filed 6–20–18; 8:45 am]
BILLING CODE 9111–45–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2018–0024; OMB No.
1660–0140]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Integrated Public
Alert and Warning Systems (IPAWS)
Memorandum of Agreement
Applications
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public to take this opportunity
to comment on an extension, without
change, of a currently approved
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28856-28857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2194]
Novartis Pharmaceuticals Corporation, et al.; Withdrawal of
Approval of Five New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of five new drug applications (NDAs) from multiple
applicants. The holders of the applications notified the Agency in
writing that the drug products were no longer marketed and requested
that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 23, 2018.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 020831............. Foradil Aerolizer Novartis
(formoterol fumarate) Pharmaceuticals
Powder, 0.012 Corp., One Health
milligram (mg)/ Pl., East Hanover, NJ
inhalation. 07936.
NDA 022504............. Axiron (testosterone) Eli Lilly and Co.,
Transdermal Metered Lilly Corporate
Solution, 30 mg/1.5 Center, Indianapolis,
milliliter (mL) IN 46285.
actuation.
NDA 050585............. Rocephin (ceftriaxone Hoffmann-La Roche,
sodium) for Injection, Inc., c/o Genentech,
equivalent to (EQ) 10 Inc., 1 DNA Way,
gram (g) base/vial, EQ South San Francisco,
250 mg base/vial (IV/ CA 94080.
IM), EQ 500 mg base/
vial (IV/IM), EQ 1 g
base/vial (IV/IM), EQ
2 g base/vial (IV/IM),
EQ 500 mg base/vial, N/
A; N/A, 1% (Rocephin
kit), EQ 1 g base/
vial, N/A; N/A, 1%
(Rocephin kit).
NDA 050624............. Rocephin (ceftriaxone Do.
sodium) with Dextrose
in Plastic Container
Injection, EQ 10 mg
base/mL, EQ 20 mg base/
mL, and EQ 40 mg base/
mL.
NDA 202763............. Testosterone Gel, 25 mg/ ANI Pharmaceuticals,
2.5 g packet, 50 mg/5 Inc., 210 Main St.
g packet. West, Baudette, MN
56623.
------------------------------------------------------------------------
[[Page 28857]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
23, 2018. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on July 23, 2018 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.
Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13293 Filed 6-20-18; 8:45 am]
BILLING CODE 4164-01-P
