Determination That Vancomycin Hydrochloride Injection Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 78747-78748 [2015-31689]
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Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–4667]
Determination That Vancomycin
Hydrochloride Injection Drug Products,
Were Not Withdrawn From Sale for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 or Agency) has
determined that VANCOCIN
(vancomycin hydrochloride (HCl))
injection, 500 milligrams (mg)/vial, 1
gram (g)/vial, 10 g/vial (‘‘the
VANCOCIN drug products’’);
VANCOLED (vancomycin HCl)
injection, 500 mg/vial, 1 g/vial, 2 g/vial,
5 g/vial, and 10 g/vial (‘‘the VANCOLED
drug products’’); and VANCOCIN
HYDROCHLORIDE (vancomycin HCl)
injection, 500 mg/vial and 1 g/vial (‘‘the
VANCOCIN HCl drug products’’)
(hereinafter collectively ‘‘these
Vancomycin HCl drug products’’), were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for these
Vancomycin HCl drug products if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Robin Fastenau, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 240–
402–4510, Robin.Fastenau@fda.hhs.gov.
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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:53 Dec 16, 2015
Jkt 238001
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)).
FDA may not approve an ANDA that
does not refer to a listed drug.
The VANCOCIN drug products are the
subject of ANDA 62–812 held by ANI
Pharmaceuticals, Inc., and were initially
approved on November 17, 1987. The
VANCOLED drug products are the
subject of ANDA 62–682 held by
`
Eurohealth International Sarl and were
initially approved on July 22, 1986. The
VANCOCIN HCl drug products are the
subject of ANDA 60–180 held by ANI
Pharmaceuticals, Inc., and were initially
approved on November 6, 1964. These
Vancomycin HCl drug products are
indicated for the treatment of serious or
severe infections caused by susceptible
strains of methicillin-resistant (betalactam-resistant) staphylococci. They
are indicated for penicillin-allergic
patients; for patients who cannot receive
or who have failed to respond to other
drugs, including the penicillins or
cephalosporins; and for infections
caused by vancomycin-susceptible
organisms that are resistant to other
antimicrobial drugs. They are indicated
for initial therapy when methicillinresistant staphylococci are suspected,
but after susceptibility data are
available, therapy should be adjusted
accordingly.
These Vancomycin HCl drug products
are currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Strides Arcolab Limited submitted a
citizen petition dated May 18, 2009
(Docket No. FDA–2009–P–0242), under
§ 10.30 (21 CFR 10.30), requesting that
the Agency determine whether
VANCOCIN (Vancomycin HCl)
injection, 10 g/vial, was withdrawn
from sale for reasons of safety or
effectiveness. Although the citizen
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
78747
petition did not address the 500 mg/vial
and 1 g/vial strengths, these strengths
have also been discontinued. On our
own initiative, we have also determined
whether these strengths were
withdrawn for safety or effectiveness
reasons. Hospira submitted a citizen
petition dated October 5, 2015 (Docket
No. FDA–2015–P–3621), under § 10.30,
requesting that the Agency determine
whether VANCOLED (vancomycin HCl)
injection, 10 g bulk packaging, was
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not address the 500
mg/vial, 1 g/vial, 2 g/vial, and 5 g/vial
strengths, these strengths have also been
discontinued. On our own initiative, we
have also determined whether these
strengths were withdrawn from sale for
reasons of safety or effectiveness. In
addition, the VANCOCIN HCl
(Vancomycin HCl), injection, 500 mg/
vial, and 1 g/vial drug products have
been discontinued from sale and FDA
has determined whether these drug
products were withdrawn from the
market for safety or effectiveness
reasons.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that these Vancomycin HCl
drug products were not withdrawn for
reasons of safety or effectiveness. The
petitioners have identified no data or
other information suggesting that these
Vancomycin HCl drug products were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of these
Vancomycin HCl drug products from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that these
drug products were not withdrawn from
sale for reasons of safety or
effectiveness.
Accordingly, the Agency will
continue to list these Vancomycin HCl
drug products 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 these Vancomycin
HCl drug products 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 these drug
products should be revised to meet
current standards, the Agency will
E:\FR\FM\17DEN1.SGM
17DEN1
78748
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
advise ANDA applicants to submit such
labeling.
Dated: December 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31689 Filed 12–16–15; 8:45 am]
BILLING CODE 4164–01–P
Information Collection Request Title:
Bureau of Health Workforce
Performance Data Collection OMB No.
0915–0061—Revision
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than February 16, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–105, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
SUMMARY:
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Abstract: Over 40 Bureau of Health
Workforce (BHW) programs award
grants to health professions schools and
training programs across the United
States to develop, expand, and enhance
training, and to strengthen the
distribution of the health workforce.
These programs are authorized by the
Public Health Service Act (42 U.S.C. 201
et seq.), specifically Titles III, VII, and
VIII. Performance information regarding
these programs is collected in the HRSA
Performance Report for Grants and
Cooperative Agreements (PRGCA). Data
collection activities consisting of an
annual progress and annual
performance report satisfy statutory and
programmatic requirements for
performance measurement and
evaluation (including specific Title III,
VII and VIII requirements), as well as
Government Performance and Results
Act (GPRA) requirements. The
performance measures were last revised
in 2013 to ensure they addressed
programmatic changes, met evolving
program management needs, and
responded to emerging workforce
concerns—especially as a result of the
changes in the Affordable Care Act (Pub.
L. 111–148). As these revisions were
successful, BHW will continue with its
current performance management
strategy and measures and require
annual progress and performance
reporting.
Need and Proposed Use of the
Information: The purpose of the
Number of
respondents
Form name
Number of
responses per
respondent
proposed data collection is to analyze
and report grantee training activities
and education, identify intended
practice locations and report outcomes
of funded initiatives. Data collected
from these grant programs will also
provide a description of the program
activities of approximately 1,700
reporting grantees to better inform
policymakers on the barriers,
opportunities, and outcomes involved
in health care workforce development.
The proposed measures focus on five
key outcomes: (1) Increasing the
workforce supply of diverse welleducated practitioners, (2) increasing
the number of practitioners that practice
in underserved and rural areas, (3)
enhancing the quality of education, (4)
increasing the recruitment, training, and
placement of under-represented groups
in the health workforce, and (5)
supporting educational infrastructure to
increase the capacity to train more
health professionals.
Likely Respondents: Respondents are
awardees of BHW health professions
grant programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Program Aggregate Data Collection* ..................................
Individual-level Data Collection ............................................
600
1,100
1
1
600
1,100
6
2
3,600
2,200
Total ..............................................................................
1,700
........................
1,700
........................
5,800
* Program aggregate data collection will only be required for programs that do not provide direct financial support to all trainees.
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16:53 Dec 16, 2015
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E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78747-78748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31689]
[[Page 78747]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-4667]
Determination That Vancomycin Hydrochloride Injection Drug
Products, 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 or Agency) has
determined that VANCOCIN (vancomycin hydrochloride (HCl)) injection,
500 milligrams (mg)/vial, 1 gram (g)/vial, 10 g/vial (``the VANCOCIN
drug products''); VANCOLED (vancomycin HCl) injection, 500 mg/vial, 1
g/vial, 2 g/vial, 5 g/vial, and 10 g/vial (``the VANCOLED drug
products''); and VANCOCIN HYDROCHLORIDE (vancomycin HCl) injection, 500
mg/vial and 1 g/vial (``the VANCOCIN HCl drug products'') (hereinafter
collectively ``these Vancomycin HCl drug products''), were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for these Vancomycin HCl drug products if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510, Robin.Fastenau@fda.hhs.gov.
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
The VANCOCIN drug products are the subject of ANDA 62-812 held by
ANI Pharmaceuticals, Inc., and were initially approved on November 17,
1987. The VANCOLED drug products are the subject of ANDA 62-682 held by
Eurohealth International S[agrave]rl and were initially approved on
July 22, 1986. The VANCOCIN HCl drug products are the subject of ANDA
60-180 held by ANI Pharmaceuticals, Inc., and were initially approved
on November 6, 1964. These Vancomycin HCl drug products are indicated
for the treatment of serious or severe infections caused by susceptible
strains of methicillin-resistant (beta-lactam-resistant) staphylococci.
They are indicated for penicillin-allergic patients; for patients who
cannot receive or who have failed to respond to other drugs, including
the penicillins or cephalosporins; and for infections caused by
vancomycin-susceptible organisms that are resistant to other
antimicrobial drugs. They are indicated for initial therapy when
methicillin-resistant staphylococci are suspected, but after
susceptibility data are available, therapy should be adjusted
accordingly.
These Vancomycin HCl drug products are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Strides Arcolab Limited submitted a citizen petition dated May 18,
2009 (Docket No. FDA-2009-P-0242), under Sec. 10.30 (21 CFR 10.30),
requesting that the Agency determine whether VANCOCIN (Vancomycin HCl)
injection, 10 g/vial, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 500
mg/vial and 1 g/vial strengths, these strengths have also been
discontinued. On our own initiative, we have also determined whether
these strengths were withdrawn for safety or effectiveness reasons.
Hospira submitted a citizen petition dated October 5, 2015 (Docket No.
FDA-2015-P-3621), under Sec. 10.30, requesting that the Agency
determine whether VANCOLED (vancomycin HCl) injection, 10 g bulk
packaging, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 500
mg/vial, 1 g/vial, 2 g/vial, and 5 g/vial strengths, these strengths
have also been discontinued. On our own initiative, we have also
determined whether these strengths were withdrawn from sale for reasons
of safety or effectiveness. In addition, the VANCOCIN HCl (Vancomycin
HCl), injection, 500 mg/vial, and 1 g/vial drug products have been
discontinued from sale and FDA has determined whether these drug
products were withdrawn from the market for safety or effectiveness
reasons.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that these Vancomycin HCl drug products
were not withdrawn for reasons of safety or effectiveness. The
petitioners have identified no data or other information suggesting
that these Vancomycin HCl drug products were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of these Vancomycin HCl drug products
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that these drug products were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list these Vancomycin HCl
drug products 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
these Vancomycin HCl drug products 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 these drug
products should be revised to meet current standards, the Agency will
[[Page 78748]]
advise ANDA applicants to submit such labeling.
Dated: December 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31689 Filed 12-16-15; 8:45 am]
BILLING CODE 4164-01-P
