Determination that Bretylium Tosylate Injection, 50 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 78669-78670 [2011-32367]
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Federal Register / Vol. 76, No. 243 / Monday, December 19, 2011 / Notices
Control Number 0910–0572) estimated
the reporting burden for a multi-year
period. We are requesting that OMB
extend approval for the information in
this collection, as described below,
which will continue to be submitted to
FDA during this multi-year period.
Annual Burden for Prescription Drug
Labeling Design, Testing, and
Submitting to FDA for New Drug
Applications (NDAs) and Biologics
License Applications (BLAs) (§§ 201.56
and 201.57) (Table 1)
New drug product applicants must:
(1) Design and create prescription drug
labeling containing Highlights,
Contents, and FPI; (2) test the designed
labeling (e.g., to ensure that the
designed labeling fits into cartonenclosed products); and (3) submit it to
78669
FDA for approval. Based on the
projected data estimated in the final
rule, FDA estimates that it takes
applicants approximately 3,349 hours to
design, test, and submit prescription
drug labeling to FDA as part of an NDA
or a BLA under the revised regulations.
Approximately 84 applicants submit
approximately 105 new applications
(NDAs and BLAs) to FDA per year,
totaling 351,645 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED REPORTING BURDEN FOR NEW DRUG APPLICATIONS 1
Category (21 CFR section)
Number of
respondents
Number of responses
per respondent
Total annual
responses
Average burden
per response
Total hours
Annual Burden for Labeling Requirements in
§§ 201.56 and 201.57 ...................................
84
1.25
105
3,349
351,645
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 14, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–32397 Filed 12–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0578]
Determination that Bretylium Tosylate
Injection, 50 Milligrams/Milliliter, Was
Not Withdrawn From Sale for Reasons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 Bretylium Tosylate injection, 50
milligrams (mg)/milliliter (mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for Bretylium
Tosylate injection, 50 mg/mL, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Molly Flannery, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6246,
Silver Spring, MD 20993–0002, (301)
796–3543.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
emcdonald on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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19:31 Dec 16, 2011
Jkt 226001
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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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.
Bretylium Tosylate injection, 50 mg/
mL, is the subject of NDA 19–030, held
by Hospira, Inc., and initially approved
on April 16, 1986. Bretylium Tosylate
injection, 50 mg/mL, is indicated in the
prophylaxis and therapy of ventricular
fibrillation and in the treatment of lifethreatening ventricular arrhythmias,
such as ventricular tachycardia, that
have failed to respond to adequate doses
of a first-line antiarrhythmic agent, such
as lidocaine.
In a letter dated June 17, 2010,
Hospira, Inc. requested withdrawal of
NDA 19–030 for Bretylium Tosylate
injection, 50 mg/mL. In the Federal
Register of June 8, 2011 (76 FR 33310),
FDA announced that it was
withdrawing approval of NDA 019030,
effective July 8, 2011.
Academic Pharmaceuticals, Inc.
submitted a citizen petition dated July
27, 2011 (Docket No. FDA–2011–P–
0578), under 21 CFR 10.30, requesting
that the Agency determine whether
Bretylium Tosylate injection, 50 mg/mL,
was 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 Bretylium Tosylate
injection, 50 mg/mL, was not
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed the information provided by
the petitioner and our files for records
concerning the withdrawal of Bretylium
E:\FR\FM\19DEN1.SGM
19DEN1
78670
Federal Register / Vol. 76, No. 243 / Monday, December 19, 2011 / Notices
Tosylate injection, 50 mg/mL, 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 product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list Bretylium Tosylate
injection, 50 mg/mL, 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 Bretylium Tosylate injection, 50 mg/
mL, 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: December 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–32367 Filed 12–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 19,
2012.
Submit written requests for
single copies of the draft guidance
document entitled ‘‘Evaluation of Sex
Differences in Medical Device Clinical
Studies’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to (301)
847–8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2011–D–0817]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Evaluation of Sex Differences in
Medical Device Clinical Studies;
Availability
Kathryn O’Callaghan, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1546, Silver Spring,
MD 20993–0002, (301) 796–6349.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Evaluation of Sex Differences
in Medical Device Clinical Studies.’’
This document provides guidance on
the study and evaluation of sex
differences in medical device clinical
trials, with a specific focus on
addressing potential differences in
study design, conduct, outcomes, and
interpretation that should be considered
to ensure sex-specific issues are
adequately addressed in clinical trials.
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
emcdonald on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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19:31 Dec 16, 2011
Jkt 226001
I. Background
The purpose of this guidance is to
outline the Center for Devices and
Radiological Health’s (CDRH’s)
expectations regarding sex-specific
patient enrollment, data analysis, and
reporting of study information. The
intent is to improve the quality and
consistency of available data regarding
the performance of medical devices in
women. This information can be of
benefit to patients and their medical
providers, as well as clinical researchers
and others. The specific objectives of
this guidance are to: (1) Better
communicate the balance of risks and
benefits of FDA-approved or cleared
medical devices; (2) identify sexspecific questions for further study; and
(3) encourage the consideration of sex
and associated covariates (e.g., body
size, plaque morphology, etc.) during
the trial design stage.
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II. Significance of Guidance
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 Agency’s current thinking
on ‘‘Evaluation of Sex Differences in
Medical Device Clinical Studies.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Evaluation of Sex Differences
in Medical Device Clinical Studies,’’
you may either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to (301) 847–8149 to
receive a hard copy. Please use the
document number 1727 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 812.25(c) have been approved
under OMB control number 0910–0078;
the collections of information in 21 CFR
part 807 Subpart E have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814 Subparts B and E have been
approved under OMB control number
0910–0231; the collections of
information in 21 CFR part 814 Subpart
H have been approved under OMB
control number 0910–0332; the
collections of information in 21 CFR
part 822 have been approved under
OMB control number 0910–0449.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78669-78670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0578]
Determination that Bretylium Tosylate Injection, 50 Milligrams/
Milliliter, Was 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
Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (mL), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for Bretylium Tosylate injection, 50 mg/mL, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6246, Silver Spring, MD 20993-0002, (301)
796-3543.
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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
Bretylium Tosylate injection, 50 mg/mL, is the subject of NDA 19-
030, held by Hospira, Inc., and initially approved on April 16, 1986.
Bretylium Tosylate injection, 50 mg/mL, is indicated in the prophylaxis
and therapy of ventricular fibrillation and in the treatment of life-
threatening ventricular arrhythmias, such as ventricular tachycardia,
that have failed to respond to adequate doses of a first-line
antiarrhythmic agent, such as lidocaine.
In a letter dated June 17, 2010, Hospira, Inc. requested withdrawal
of NDA 19-030 for Bretylium Tosylate injection, 50 mg/mL. In the
Federal Register of June 8, 2011 (76 FR 33310), FDA announced that it
was withdrawing approval of NDA 019030, effective July 8, 2011.
Academic Pharmaceuticals, Inc. submitted a citizen petition dated
July 27, 2011 (Docket No. FDA-2011-P-0578), under 21 CFR 10.30,
requesting that the Agency determine whether Bretylium Tosylate
injection, 50 mg/mL, was 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 Sec. 314.161 that Bretylium Tosylate injection, 50 mg/mL, was
not withdrawn for reasons of safety or effectiveness. We have carefully
reviewed the information provided by the petitioner and our files for
records concerning the withdrawal of Bretylium
[[Page 78670]]
Tosylate injection, 50 mg/mL, 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 product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list Bretylium Tosylate
injection, 50 mg/mL, 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 Bretylium Tosylate injection, 50 mg/mL, 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: December 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32367 Filed 12-16-11; 8:45 am]
BILLING CODE 4160-01-P
