Determination That KEFLEX (Cephalexin) Capsule, Equivalent to 333 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 20357-20358 [2011-8617]
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20357
Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices
and other conditions of their approved
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Respondents: Title IV–E Agencies.
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SACWIS Assessment Review Guide ..............................................................
Estimated Total Annual Burden
Hours: 750.
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[FR Doc. 2011–8663 Filed 4–11–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
srobinson on DSKHWCL6B1PROD with NOTICES
[Docket No. FDA–2009–P–0256]
Determination That KEFLEX
(Cephalexin) Capsule, Equivalent to
333 Milligrams Base, 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Withdrawn From Sale for Reasons of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 KEFLEX (cephalexin) capsule,
SUMMARY:
VerDate Mar<15>2010
18:00 Apr 11, 2011
Jkt 223001
Number of
responses per
respondent
Number of
respondents
Instrument
3
equivalent to (EQ) 333 milligrams (mg)
base, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for cephalexin
capsule, EQ 333 mg base, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
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 approved
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,
a drug is 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).
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
1
Average
burden hours
per response
250
Total burden
hours
750
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
KEFLEX (cephalexin) capsule, EQ 333
mg base, is the subject of NDA 050405
held by Victory Pharma, Inc., and the
333-mg strength was approved on May
12, 2006. KEFLEX is a cephalosporin
antibiotic indicated for the treatment of
respiratory tract infections caused by
Streptococcus pneumoniae and S.
pyogenes, as well as certain other
infections caused by susceptible strains
of certain designated micro-organisms
as described in the product labeling.
KEFLEX (cephalexin) capsule, EQ 333
mg base, has never been marketed. In
previous instances (see 72 FR 9763,
March 5, 2007; 61 FR 25497, May 21,
1996), the Agency has determined that,
for purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated May
29, 2009 (Docket No. FDA–2009–P–
0256), under 21 CFR 10.30, requesting
that the Agency determine whether
KEFLEX (cephalexin) capsule, EQ 333
mg base, was withdrawn from sale for
reasons of safety or effectiveness. After
considering the citizen petition and
reviewing Agency records, FDA has
determined under § 314.161 that
KEFLEX (cephalexin) capsule, EQ 333
mg base, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that KEFLEX
(cephalexin) capsule, EQ 333 mg base,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of KEFLEX
(cephalexin) capsule, EQ 333 mg base,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
E:\FR\FM\12APN1.SGM
12APN1
20358
Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices
that would indicate that this product
was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list KEFLEX (cephalexin)
capsule, EQ 333 mg base, 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 KEFLEX (cephalexin) capsule, EQ
333 mg base, 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: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8617 Filed 4–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
srobinson on DSKHWCL6B1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases
Diabetes Mellitus Interagency
Coordinating Committee; Notice of
Workshop
The Diabetes Mellitus Interagency
Coordinating Committee (DMICC) will
hold a 2-day workshop on May 5, from
8 a.m. to 6 p.m., and May 6, from
7:30 a.m. to 4 p.m., at the Hilton
Washington DC/Rockville Hotel &
Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
The workshop will be open to the
public, with attendance limited to space
available. Non-Federal individuals
planning to attend the workshop should
register on the workshop Web site
(https://conferences.thehillgroup.com/
NIDDK/DMICCworkshop/) at
least 7 days prior to the workshop.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
inform the Contact Person listed below
at least 10 days in advance of the
workshop.
The DMICC facilitates cooperation,
communication, and collaboration on
diabetes among government entities.
The May 5–6, 2011, DMICC workshop
will discuss new and emerging
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18:00 Apr 11, 2011
Jkt 223001
opportunities for type 1 diabetes
research supported by the Special
Statutory Funding Program for Type 1
Diabetes Research.
Any interested person may file
written comments with the Committee
by forwarding their statement to the
Contact Person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Because of time constraints for the
workshop, there will not be time on the
agenda for oral comments from
members of the public.
An agenda for the DMICC workshop
will be available on the following Web
site: https://
conferences.thehillgroup.com/NIDDK/
DMICCworkshop/. Members
of the public who would like to receive
e-mail notification about future DMICC
meetings could register on a listserv
available on the DMICC Web site:
https://www.diabetescommittee.gov.
For further information concerning
this workshop, contact Dr. Sanford
Garfield, Executive Secretary of the
Diabetes Mellitus Interagency
Coordinating Committee, National
Institute of Diabetes and Digestive and
Kidney Diseases, 6707 Democracy
Boulevard, Room 654, MSC 5460,
Bethesda, MD 20892–5460, Telephone:
301- 594–8803 Fax: 301–402–6271,
E-mail: dmicc@mail.nih.gov.
Dated: April 4, 2011.
Sanford Garfield,
Executive Secretary, DMICC, Division of
Diabetes, Endocrinology and Metabolic
Diseases, NIDDK, National Institutes of
Health.
[FR Doc. 2011–8612 Filed 4–11–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Career Enhancement Award for Stem Cell
Research.
Date: May 4, 2011.
Time: 12:30 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call)
Contact Person: William J. Johnson, PhD,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: April 5, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–8610 Filed 4–11–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The concept review and
evaluation discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Folic Acid/Zinc
Sulfate Supplementation, Semen Quality,
and Ovulation Induction/IVF Outcomes.
Date: April 12, 2011.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate concept
review.
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20357-20358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8617]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-P-0256]
Determination That KEFLEX (Cephalexin) Capsule, Equivalent to 333
Milligrams Base, 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
KEFLEX (cephalexin) capsule, equivalent to (EQ) 333 milligrams (mg)
base, was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for cephalexin capsule, EQ 333 mg base,
if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.
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 approved 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, a drug is 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). Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
KEFLEX (cephalexin) capsule, EQ 333 mg base, is the subject of NDA
050405 held by Victory Pharma, Inc., and the 333-mg strength was
approved on May 12, 2006. KEFLEX is a cephalosporin antibiotic
indicated for the treatment of respiratory tract infections caused by
Streptococcus pneumoniae and S. pyogenes, as well as certain other
infections caused by susceptible strains of certain designated micro-
organisms as described in the product labeling.
KEFLEX (cephalexin) capsule, EQ 333 mg base, has never been
marketed. In previous instances (see 72 FR 9763, March 5, 2007; 61 FR
25497, May 21, 1996), the Agency has determined that, for purposes of
Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
Lachman Consultant Services, Inc., submitted a citizen petition
dated May 29, 2009 (Docket No. FDA-2009-P-0256), under 21 CFR 10.30,
requesting that the Agency determine whether KEFLEX (cephalexin)
capsule, EQ 333 mg base, was withdrawn from sale for reasons of safety
or effectiveness. After considering the citizen petition and reviewing
Agency records, FDA has determined under Sec. 314.161 that KEFLEX
(cephalexin) capsule, EQ 333 mg base, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that KEFLEX (cephalexin) capsule, EQ 333 mg
base, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
KEFLEX (cephalexin) capsule, EQ 333 mg base, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information
[[Page 20358]]
that would indicate that this product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list KEFLEX (cephalexin)
capsule, EQ 333 mg base, 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 KEFLEX (cephalexin) capsule, EQ 333
mg base, 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: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8617 Filed 4-11-11; 8:45 am]
BILLING CODE 4160-01-P
