Determination That ORLAAM (Levomethadyl Acetate Hydrochloride) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 32366-32367 [2011-13884]
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Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
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jlentini on DSK4TPTVN1PROD with NOTICES
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BiologicsBloodVaccines/
ScienceResearch/ucm251665.htm and/
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16:06 Jun 03, 2011
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13885 Filed 6–3–11; 8:45 am]
A. Award Amount
VerDate Mar<15>2010
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Jkt 223001
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2007–P–0347 formerly
2007P–0431/CP1 and FDA–2010–P–0505]
Determination That ORLAAM
(Levomethadyl Acetate Hydrochloride)
Oral Solution, 10 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Was Not Withdrawn From Sale for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 ORLAAM (levomethadyl acetate
hydrochloride (HCl)) oral solution, 10
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withdrawn from sale for reasons of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 levomethadyl
acetate HCl oral solution, 10 mg/mL, if
all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Sandra Park, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6221, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
SUMMARY:
PO 00000
Frm 00012
Fmt 4703
Sfmt 4703
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,
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).
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.
ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, is the subject
of NDA 20–315, held by Roxane
Laboratories, Inc. (Roxane), and
approved on July 9, 1993. ORLAAM is
indicated for the management of opiate
dependence, reserved for use in
treatment of opiate-addicted patients
who fail to show an acceptable response
to other adequate treatments for opiate
addiction, either because of insufficient
effectiveness or the inability to achieve
effective dose due to intolerable adverse
effects from those drugs.
In a letter dated April 10, 2003,
Roxane notified FDA that ORLAAM
(levomethadyl acetate HCl) oral
solution, 10 mg/mL, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA
E:\FR\FM\06JNN1.SGM
06JNN1
jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
announced that it was withdrawing
approval of NDA 20–315, effective
December 7, 2007.
Charles O’Keeffe of the Virginia
Commonwealth University School of
Medicine submitted two citizen
petitions, one dated October 31, 2007
(Docket No. FDA–2007–P–0347), and
the second dated September 22, 2010
(Docket No. FDA–2010–P–0505), under
21 CFR 10.30, requesting that the agency
determine whether ORLAAM
(levomethadyl acetate HCl) oral
solution, 10 mg/mL, 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
ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that ORLAAM (levomethadyl
acetate HCl) oral solution, 10 mg/mL,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ORLAAM
(levomethadyl acetate HCl) oral
solution, 10 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 ORLAAM (levomethadyl acetate
HCl) oral solution, 10 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 ORLAAM (levomethadyl acetate HCl)
oral solution, 10 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
Food and Drug Administration
Federal Emergency Management
Agency
[Docket No. FDA–1999–D–0742 (formerly
Docket No. 1999D–4396)]
[Docket ID FEMA–2011–0013; OMB No.
1660–0106]
Draft Guidance for Clinical
Investigators, Industry, and FDA Staff:
Financial Disclosure by Clinical
Investigators; Correction
Agency Information Collection
Activities, Proposed Collection;
Comment Request; Integrated Public
Alert and Warning Systems (IPAWS)
Inventory
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of May 24, 2011 (76 FR 30175).
The document announced the
availability of a draft guidance entitled
‘‘ Draft Guidance for Clinical
Investigators, Industry, and FDA Staff:
Financial Disclosure by Clinical
Investigators.’’The document was
published with an incorrect docket
number. This document corrects that
error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3208,
Silver Spring, MD 20993–0002, 301–
796–9148.
In FR Doc.
2011–12623, appearing on page 30175,
in the Federal Register of Tuesday, May
24, 2011, the following correction is
made:
1. On page 30175, in the second
column, in the Docket No. heading,
‘‘[Docket No. FDA–1999–D–0792]
(Formerly FDA–1999–D–0792)’’ is
corrected to read ‘‘[Docket No. FDA–
1999–D–0742] (formerly Docket No.
1999D–4396)’’.
SUPPLEMENTARY INFORMATION:
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13871 Filed 6–3–11; 8:45 am]
BILLING CODE 4160–01–P
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13884 Filed 6–3–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:06 Jun 03, 2011
Jkt 223001
32367
PO 00000
Frm 00013
Fmt 4703
Sfmt 4703
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
revision of a continuing information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning the
proposed revision of the information
collection concerning public alert and
warning systems at the Federal, State,
territorial, Tribal and local levels of
government which is necessary for the
inventory and evaluation and
assessment of existing public alert and
warning resources and their integration
with the Integrated Public Alert and
Warning System.
DATES: Comments must be submitted on
or before August 5, 2011.
ADDRESSES: To avoid duplicate
submissions to the docket, please use
only one of the following means to
submit comments:
(1) Online. Submit comments at
https://www.regulations.gov under
Docket ID FEMA–2011–0013. Follow
the instructions for submitting
comments.
(2) Mail. Submit written comments to
Docket Manager, Office of Chief
Counsel, DHS/FEMA, 500 C Street, SW.,
Room 835, Washington, DC 20472–
3100.
(3) Facsimile. Submit comments to
(703) 483–2999.
(4) E-mail. Submit comments to
FEMA-POLICY@dhs.gov. Include Docket
ID FEMA–2011–0013 in the subject line.
All submissions received must
include the agency name and Docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
SUMMARY:
E:\FR\FM\06JNN1.SGM
06JNN1
]]>Agencies
[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32366-32367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13884]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2007-P-0347 formerly 2007P-0431/CP1 and FDA-2010-P-
0505]
Determination That ORLAAM (Levomethadyl Acetate Hydrochloride)
Oral Solution, 10 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
ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10
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 levomethadyl
acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Sandra Park, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6221, 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 (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). 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.
ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, is the
subject of NDA 20-315, held by Roxane Laboratories, Inc. (Roxane), and
approved on July 9, 1993. ORLAAM is indicated for the management of
opiate dependence, reserved for use in treatment of opiate-addicted
patients who fail to show an acceptable response to other adequate
treatments for opiate addiction, either because of insufficient
effectiveness or the inability to achieve effective dose due to
intolerable adverse effects from those drugs.
In a letter dated April 10, 2003, Roxane notified FDA that ORLAAM
(levomethadyl acetate HCl) oral solution, 10 mg/mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA
[[Page 32367]]
announced that it was withdrawing approval of NDA 20-315, effective
December 7, 2007.
Charles O'Keeffe of the Virginia Commonwealth University School of
Medicine submitted two citizen petitions, one dated October 31, 2007
(Docket No. FDA-2007-P-0347), and the second dated September 22, 2010
(Docket No. FDA-2010-P-0505), under 21 CFR 10.30, requesting that the
agency determine whether ORLAAM (levomethadyl acetate HCl) oral
solution, 10 mg/mL, 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 ORLAAM
(levomethadyl acetate HCl) oral solution, 10 mg/mL, was not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that ORLAAM (levomethadyl
acetate HCl) oral solution, 10 mg/mL, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ORLAAM (levomethadyl acetate HCl)
oral solution, 10 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 ORLAAM (levomethadyl
acetate HCl) oral solution, 10 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 ORLAAM (levomethadyl acetate HCl)
oral solution, 10 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: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13884 Filed 6-3-11; 8:45 am]
BILLING CODE 4160-01-P
