Determination That ALBAMYCIN (Novobiocin Sodium) Capsule, 250 Milligrams, Was Withdrawn From Sale for Reasons of Safety or Effectiveness, 3143-3144 [2011-1000]
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Child Care; Delegation of
Authority
mstockstill on DSKH9S0YB1PROD with NOTICES
Notice is hereby given that I have
delegated to the Director, Office of Child
Care, Administration for Children and
Families, the authorities vested in me by
the Secretary of Health and Human
Services in the memorandum dated
August 20, 1991, pertaining to the Head
Start Program and the Child
Development Associate Scholarship
Assistance Grants Program; in the
memorandum dated August 20, 1991,
pertaining to the Omnibus Budget
Reconciliation Act of 1981; in the
memorandum dated August 20, 1991,
pertaining to the Omnibus Budget
Reconciliation Act of 1990 (OBRA 1990,
Pub. L. 101–508); and in the
memorandum dated September 16,
1997, pertaining to the Personal
Responsibility and Work Opportunity
Reconciliation Act of 1996 (PRWORA,
Pub. L. 104–193), as amended, as they
pertain to the functions assigned to the
Office of Child Care.
(a) Authorities Delegated
1. Authority to administer the
provisions of the Child Development
Associate Scholarship Assistance Act,
42 U.S.C. 10901–10905, and as amended
now and hereafter.
2. Authority to administer the
provisions of Subchapter D—Grants for
Planning and Development of
Dependent Care Programs and for other
purposes (Chapter 8, Title VI of the
Omnibus Budget Reconciliation Act of
1981, Pub. L. 97–35, 42 U.S.C. 9871 et
seq.) and as amended now and
hereafter.
3. Authority for the Child Care and
Development Block Grants, under
Section 5082 of OBRA 1990, (42 U.S.C.
9858 et seq.), and as amended now and
hereafter.
4. Authority to administer the
provisions of the Child Care and
Development Block Grant Amendments
of 1996, 42 U.S.C. 9801 note, under
Sections 601–615 of the Personal
Responsibility and Work Opportunity
Reconciliation Act of 1996, 42 U.S.C.
1305 note, 42 U.S.C. 601 et seq., and as
amended now and hereafter.
(b) Limitations
1. These authorities shall be exercised
under the Department’s policy on
regulations and the existing delegation
of authority to approve and issue
regulations.
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17:04 Jan 18, 2011
Jkt 223001
2. This delegation does not include
the authority to submit reports to
Congress and shall be exercised under
financial and administrative
requirements applicable to all
Administration for Children and
Families authorities.
3. The approval or disapproval of
grant applications and the making of
grant awards require concurrence of the
appropriate Grants Officer. The
approval or disapproval of contract
proposals and awards are subject to the
requirements of the Federal Acquisition
Regulations and requires the
concurrence of the Contracting Officer.
4. This delegation of authority does
not include the authority to sign and
issue notices of grant awards.
5. This delegation of authority does
not include the authority to appoint
Action Officials for Audit Resolution.
6. This delegation of authority does
not include the authority to appoint
Central Office or Regional Office Grant
Officers for the administration of the
child care related programs.
7. This delegation of authority does
not include the authority to hold
hearings.
8. This delegation of authority does
not include the authority to approve or
disapprove awards for grants or
contracts for research, demonstration, or
evaluations relating to child care.
9. Any re-delegation shall be in
writing and prompt notification must be
provided to all affected managers,
supervisors, and other personnel, and
requires the concurrence of the Deputy
Assistant Secretary for Administration.
(c) Effect on Existing Delegations
This delegation supersedes all
existing delegations of these authorities.
(d) Effective Date
This delegation is effective
immediately. I hereby affirm and ratify
any actions taken by the Director, Office
of Child Care, or his or her subordinates,
which involved the exercise of the
authorities delegated herein prior to the
effective date of this delegation.
Dated: January 10, 2011.
David A. Hansell,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2011–1067 Filed 1–18–11; 8:45 am]
BILLING CODE 4184–01–P
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3143
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0431]
Determination That ALBAMYCIN
(Novobiocin Sodium) Capsule, 250
Milligrams, Was 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 ALBAMYCIN (novobiocin sodium)
capsule, 250 milligrams (mg) was
withdrawn from sale for reasons of
safety or effectiveness. The Agency will
not accept or approve abbreviated new
drug applications (ANDAs) for
ALBAMYCIN (novobiocin sodium)
capsule, 250 mg.
FOR FURTHER INFORMATION CONTACT:
Nancy Hayes, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–3601.
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 (FD&C
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
SUMMARY:
E:\FR\FM\19JAN1.SGM
19JAN1
mstockstill on DSKH9S0YB1PROD with NOTICES
3144
Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices
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 § 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.
ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, is the subject of NDA
50–339, held by Pfizer, Inc. (Pfizer), and
initially approved on September 4,
1964. ALBAMYCIN is indicated for the
treatment of serious infections due to
susceptible strains of Staphylococcus
aureus when other less toxic antibiotics
such as the penicillins, cephalosporins,
vancomycin, lincomycin, erythromycin,
and the tetracyclines cannot be used.
Novobiocin antibiotic drug products
were reviewed for efficacy under the
Drug Efficacy Study Implementation
(DESI) program. Under this program,
implemented in response to the 1962
amendments to the FD&C Act requiring
demonstration of effectiveness (The
Kefauver-Harris Amendments, Public
Law 87–781 (1962)), the National
Academy of Sciences-National Research
Council (NAS–NRC) undertook a study
of some 4,000 drug formulations to
assess the efficacy of the products. Upon
consideration of the findings and
recommendations of the NAS–NRC,
FDA set forth in the Federal Register its
conclusions and assessment of whether
and under what circumstances the
reviewed drug products are considered
‘‘effective’’ for use as required by the
FD&C Act.
In the Federal Register of May 2, 1969
(34 FR 7252), FDA announced its
conclusions following consideration of
the findings and recommendations of
the NAS–NRC regarding oral and
parenteral forms of novobiocin
including ALBAMYCIN (novobiocin
sodium) capsule, 250 mg. The
announcement stated that FDA had
concluded that novobiocin is effective
for certain indications and provided
labeling guidelines in accordance with
this conclusion. We note, however, that
the initial panel review of a syrup form
of novobiocin raised questions, even at
that time, concerning the safety and
effectiveness of this antibiotic. The
panel report included the following
statement: ‘‘The development of safer
and more effective drugs has virtually
eliminated the need for novobiocin. The
majority of the Panel believes that orally
administered novobiocin should be
taken off the market.’’ Report of the
VerDate Mar<15>2010
17:04 Jan 18, 2011
Jkt 223001
Anti-Infectives Panel, National
Academy of Sciences-National Research
Council, Albamycin Syrup.
In an annual report received on June
9, 1999, Pharmacia & Upjohn (now
Pfizer, Inc.) notified FDA that
ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, was no longer being
manufactured. In a letter dated June 27,
2007, Pfizer, then the current holder of
NDA 50–339, notified FDA that
ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, had been
discontinued. In the Federal Register of
February 11, 2009 (74 FR 6896), FDA
announced that it was withdrawing
approval of NDA 50–339 in response to
Pfizer’s withdrawal request. As a result,
ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, was moved to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Crixmore LLC submitted a citizen
petition dated July 9, 2008 (Docket No.
FDA–2008–P–0431), under 21 CFR
10.30, requesting that the Agency
determine whether ALBAMYCIN
(novobiocin sodium) capsule, 250 mg,
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
ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, was withdrawn for
reasons of safety or effectiveness. The
petitioner stated that it had identified
no data or other information suggesting
that ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, was withdrawn for
reasons of safety or effectiveness and
speculated that the discontinuation of
this product was an economic/strategic
decision totally unrelated to safety and/
or efficacy. We have carefully reviewed
our files for records concerning the
withdrawal of ALBAMYCIN
(novobiocin sodium) capsule, 250 mg,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. The literature and adverse event
reports reveal several significant safety
concerns. Reported adverse reactions
include relatively common skin
reactions, jaundice, hepatic failure, and
blood dyscrasias (neutropenia, anemia,
and thrombocytopenia). The literature
also reveals concern about the
development of novobiocin-resistant
Staphylococci during treatment, and a
potential for drug interactions. In light
of the significant safety concerns with
this product, we conclude that the
withdrawal of this product from the
market was on the basis of safety or
effectiveness.
Accordingly, the Agency will remove
ALBAMYCIN (novobiocin sodium)
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
capsule, 250 mg, from the list of drug
products published in the Orange Book.
FDA will not accept or approve ANDAs
that refer to this drug product.
Dated: January 13, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–1000 Filed 1–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0024]
Draft Guidance for Industry on Size of
Beads in Drug Products Labeled for
Sprinkle; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Size of Beads in Drug
Products Labeled for Sprinkle.’’ This
draft guidance provides sponsors of new
drug applications (NDAs), abbreviated
new drug applications (ANDAs), and
biologics licensing applications (BLAs)
the Center for Drug Evaluation and
Research’s (CDER’s) current thinking on
appropriate size ranges for beads in drug
products that are labeled to be
administered via sprinkling (e.g.,
capsules or packets containing beads).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on 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 April 19, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
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.
SUMMARY:
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3143-3144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1000]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0431]
Determination That ALBAMYCIN (Novobiocin Sodium) Capsule, 250
Milligrams, Was 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
ALBAMYCIN (novobiocin sodium) capsule, 250 milligrams (mg) was
withdrawn from sale for reasons of safety or effectiveness. The Agency
will not accept or approve abbreviated new drug applications (ANDAs)
for ALBAMYCIN (novobiocin sodium) capsule, 250 mg.
FOR FURTHER INFORMATION CONTACT: Nancy Hayes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.
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 (FD&C 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
[[Page 3144]]
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.
ALBAMYCIN (novobiocin sodium) capsule, 250 mg, is the subject of
NDA 50-339, held by Pfizer, Inc. (Pfizer), and initially approved on
September 4, 1964. ALBAMYCIN is indicated for the treatment of serious
infections due to susceptible strains of Staphylococcus aureus when
other less toxic antibiotics such as the penicillins, cephalosporins,
vancomycin, lincomycin, erythromycin, and the tetracyclines cannot be
used.
Novobiocin antibiotic drug products were reviewed for efficacy
under the Drug Efficacy Study Implementation (DESI) program. Under this
program, implemented in response to the 1962 amendments to the FD&C Act
requiring demonstration of effectiveness (The Kefauver-Harris
Amendments, Public Law 87-781 (1962)), the National Academy of
Sciences-National Research Council (NAS-NRC) undertook a study of some
4,000 drug formulations to assess the efficacy of the products. Upon
consideration of the findings and recommendations of the NAS-NRC, FDA
set forth in the Federal Register its conclusions and assessment of
whether and under what circumstances the reviewed drug products are
considered ``effective'' for use as required by the FD&C Act.
In the Federal Register of May 2, 1969 (34 FR 7252), FDA announced
its conclusions following consideration of the findings and
recommendations of the NAS-NRC regarding oral and parenteral forms of
novobiocin including ALBAMYCIN (novobiocin sodium) capsule, 250 mg. The
announcement stated that FDA had concluded that novobiocin is effective
for certain indications and provided labeling guidelines in accordance
with this conclusion. We note, however, that the initial panel review
of a syrup form of novobiocin raised questions, even at that time,
concerning the safety and effectiveness of this antibiotic. The panel
report included the following statement: ``The development of safer and
more effective drugs has virtually eliminated the need for novobiocin.
The majority of the Panel believes that orally administered novobiocin
should be taken off the market.'' Report of the Anti-Infectives Panel,
National Academy of Sciences-National Research Council, Albamycin
Syrup.
In an annual report received on June 9, 1999, Pharmacia & Upjohn
(now Pfizer, Inc.) notified FDA that ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, was no longer being manufactured. In a letter dated
June 27, 2007, Pfizer, then the current holder of NDA 50-339, notified
FDA that ALBAMYCIN (novobiocin sodium) capsule, 250 mg, had been
discontinued. In the Federal Register of February 11, 2009 (74 FR
6896), FDA announced that it was withdrawing approval of NDA 50-339 in
response to Pfizer's withdrawal request. As a result, ALBAMYCIN
(novobiocin sodium) capsule, 250 mg, was moved to the ``Discontinued
Drug Product List'' section of the Orange Book.
Crixmore LLC submitted a citizen petition dated July 9, 2008
(Docket No. FDA-2008-P-0431), under 21 CFR 10.30, requesting that the
Agency determine whether ALBAMYCIN (novobiocin sodium) capsule, 250 mg,
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 ALBAMYCIN
(novobiocin sodium) capsule, 250 mg, was withdrawn for reasons of
safety or effectiveness. The petitioner stated that it had identified
no data or other information suggesting that ALBAMYCIN (novobiocin
sodium) capsule, 250 mg, was withdrawn for reasons of safety or
effectiveness and speculated that the discontinuation of this product
was an economic/strategic decision totally unrelated to safety and/or
efficacy. We have carefully reviewed our files for records concerning
the withdrawal of ALBAMYCIN (novobiocin sodium) capsule, 250 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. The literature and adverse
event reports reveal several significant safety concerns. Reported
adverse reactions include relatively common skin reactions, jaundice,
hepatic failure, and blood dyscrasias (neutropenia, anemia, and
thrombocytopenia). The literature also reveals concern about the
development of novobiocin-resistant Staphylococci during treatment, and
a potential for drug interactions. In light of the significant safety
concerns with this product, we conclude that the withdrawal of this
product from the market was on the basis of safety or effectiveness.
Accordingly, the Agency will remove ALBAMYCIN (novobiocin sodium)
capsule, 250 mg, from the list of drug products published in the Orange
Book. FDA will not accept or approve ANDAs that refer to this drug
product.
Dated: January 13, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-1000 Filed 1-18-11; 8:45 am]
BILLING CODE 4160-01-P
