Determination That DIAMOX (Acetazolamide) Intravenous, 500 Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 64201-64202 [2014-25534]
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Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices
64201
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
.......................................................................
........................
........................
........................
Type of respondents
Total ...............................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–25562 Filed 10–27–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–P–0979]
Determination That DIAMOX
(Acetazolamide) Intravenous, 500
Milligrams Base/Vial, and DIAMOX
(Acetazolamide) Tablets, 125
Milligrams and 250 Milligrams, 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Not Withdrawn From Sale for Reasons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) has determined
that DIAMOX (acetazolamide)
intravenous, 500 milligrams (mg) base/
vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
these products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6228, Silver Spring,
MD 20993–0002, 240–402–4191.
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
asabaliauskas on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:06 Oct 27, 2014
Jkt 235001
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 (§ 314.162 (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.
DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, is the
subject of NDA 009–388, held by Teva
Branded Pharmaceutical Products R&D,
Inc., and initially approved on June 25,
1954. DIAMOX (acetazolamide) tablets,
125 mg and 250 mg, are the subject of
NDA 008–943, held by Teva Branded
Pharmaceutical Products R&D, Inc., and
initially approved on July 27, 1953.
DIAMOX (acetazolamide) intravenous,
500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, are indicated for adjunctive
treatment of: Edema due to congestive
heart failure; drug-induced edema;
centrencephalic epilepsies (petit mal,
unlocalized seizures); and chronic
simple (open-angle) glaucoma,
secondary glaucoma, and preoperatively
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Total burden
hours
386
in acute angle-closure glaucoma where
delay of surgery is desired in order to
lower intraocular pressure. DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 mg, are also
indicated for the prevention or
amelioration of symptoms associated
with acute mountain sickness in
climbers attempting rapid ascent and in
those who are very susceptible to acute
mountain sickness despite gradual
ascent.
DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, and
DIAMOX (acetazolamide) tablets, 125
mg and 250 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Emcure Pharmaceuticals USA, Inc.,
submitted a citizen petition dated July
3, 2014 (Docket No. FDA–2014–P–
0979), under 21 CFR 10.30, requesting
that the Agency determine that
DIAMOX (acetazolamide) intravenous,
500 mg base/vial, was discontinued for
reasons unrelated to safety and
effectiveness. Although the citizen
petition did not address DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, since those products have also been
discontinued, on our own initiative, we
therefore determined whether DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, were withdrawn for safety or
effectiveness reasons.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
DIAMOX (acetazolamide) intravenous,
500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 mg from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that these products were
E:\FR\FM\28OCN1.SGM
28OCN1
64202
Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 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. FDA will not
begin procedures to withdraw approval
of ANDAs that refer to DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 mg. Additional
ANDAs that refer to these products may
also 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 these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: October 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25534 Filed 10–27–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Generic Clearance
for Satisfaction Surveys of Customers
(CSR)
Under the provisions of
Section 3507(a)(l)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
SUMMARY:
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on August 21,
2014, page 49523 and allowed 60 days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The Center
for Scientific Review (CSR), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 31, 2014, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project
contact: Dr. Mary Ann Guadagno,
Project Clearance Liaison, Center for
Scientific Review, NIH, Room 3182,
6701 Rockledge Drive, Bethesda, MD
20892, or call non-toll-free number (301)
435–1251 or Email your request,
including your address to: guadagma@
csr.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Generic
Clearance for Satisfaction Surveys of
Customers (CSR), 0925–0474—
extension, Center for Scientific Review
(CSR), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The information collected in
these surveys will be used by the Center
for Scientific Review management and
personnel: (1) To assess the quality of
the modified operations and processes
now used by CSR to review grant
applications; (2) To assess the quality of
service provided by CSR to our
customers; (3) To enable identification
of the most promising biomedical
research that will have the greatest
impact on improving public health by
using a peer review process that is fair
unbiased from outside influence, timely,
and (4) To develop new modes of
operation based on customer need and
customer feedback about the efficacy of
implemented modifications. These
surveys will almost certainly lead to
quality improvement activities to
enhance and/or streamline CSR’s
operations. The major mechanism by
which CSR will request input is through
surveys. The major initiatives ongoing at
the present time include: Evaluation of
the peer review process, surveys of new
and early stage investigators,
satisfaction with study section meetings
using alternative review platforms,
quick feedback for peer review,
satisfaction with new reviewer
orientation sessions, teleworker space
needs, improving study section
alignment to ensure the best reviews,
and others. Surveys will be collected via
Internet or in focus groups. Information
gathered from these surveys will be
presented to, and used directly by, CSR
management to enhance the operations,
processes, organization of, and services
provided by the Center.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4323.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
A ...............
B ...............
asabaliauskas on DSK4SPTVN1PROD with NOTICES
Form name
Adult scientific professionals (via Mail/Telephone/Internet) ......
Adult scientific professionals (via focus groups) .......................
VerDate Sep<11>2014
20:06 Oct 27, 2014
Jkt 235001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
7925
240
E:\FR\FM\28OCN1.SGM
Average
burden per
response
(in hours)
1
1
28OCN1
30/60
90/60
Total annual
burden hour
3963
360
]]>Agencies
[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Notices]
[Pages 64201-64202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-P-0979]
Determination That DIAMOX (Acetazolamide) Intravenous, 500
Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125
Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
DIAMOX (acetazolamide) intravenous, 500 milligrams (mg) base/vial, and
DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn
from sale for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to withdraw approval of
abbreviated new drug applications (ANDAs) that refer to these drug
products, and it will allow FDA to continue to approve ANDAs that refer
to these products, if all other legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 240-402-4191.
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
(Sec. 314.162 (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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
DIAMOX (acetazolamide) intravenous, 500 mg base/vial, is the
subject of NDA 009-388, held by Teva Branded Pharmaceutical Products
R&D, Inc., and initially approved on June 25, 1954. DIAMOX
(acetazolamide) tablets, 125 mg and 250 mg, are the subject of NDA 008-
943, held by Teva Branded Pharmaceutical Products R&D, Inc., and
initially approved on July 27, 1953. DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, and DIAMOX (acetazolamide) tablets, 125
mg and 250 mg, are indicated for adjunctive treatment of: Edema due to
congestive heart failure; drug-induced edema; centrencephalic
epilepsies (petit mal, unlocalized seizures); and chronic simple (open-
angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-
closure glaucoma where delay of surgery is desired in order to lower
intraocular pressure. DIAMOX (acetazolamide) intravenous, 500 mg base/
vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, are also
indicated for the prevention or amelioration of symptoms associated
with acute mountain sickness in climbers attempting rapid ascent and in
those who are very susceptible to acute mountain sickness despite
gradual ascent.
DIAMOX (acetazolamide) intravenous, 500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250 mg, are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Emcure Pharmaceuticals USA, Inc., submitted a citizen petition
dated July 3, 2014 (Docket No. FDA-2014-P-0979), under 21 CFR 10.30,
requesting that the Agency determine that DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, was discontinued for reasons unrelated
to safety and effectiveness. Although the citizen petition did not
address DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, since those
products have also been discontinued, on our own initiative, we
therefore determined whether DIAMOX (acetazolamide) tablets, 125 mg and
250 mg, were withdrawn for safety or effectiveness reasons.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that DIAMOX
(acetazolamide) intravenous, 500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of DIAMOX (acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events and have found no information
that would indicate that these products were
[[Page 64202]]
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DIAMOX
(acetazolamide) intravenous, 500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250 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. FDA will not begin procedures to withdraw approval of
ANDAs that refer to DIAMOX (acetazolamide) intravenous, 500 mg base/
vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg. Additional
ANDAs that refer to these products may also 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 these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: October 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25534 Filed 10-27-14; 8:45 am]
BILLING CODE 4164-01-P
