Determination That DECASPRAY (Dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (Dexamethasone) Topical Aerosol, 0.01%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 7219-7220 [2011-2890]
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Federal Register / Vol. 76, No. 27 / Wednesday, February 9, 2011 / Notices
September 30, 2011. Consistent with the
statute and regulations, ACF requests
revision of the ACF 118–A with minor
corrections and modifications.
The Office of Child Care (OCC) has
given thoughtful consideration to the
comments received from the 1st Public
Notice. OCC has revised the document
to reflect some of the changes made to
minimize the burden of the collection of
information on respondents. The
revised document contains revisions to
improve the accuracy and clarity of
questions in order to improve the
quality of information that is collected.
This second Public Comment Period
provides an opportunity for the public
to submit comments to the Office of
Management and Budget (OMB).
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
7219
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
Respondents:
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
CCDF Tribal Plan ............................................................................
257
0.5
120
15,420
............................
............................
............................
15,420
Estimated Total Annual Burden Hours .....................................
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: February 2, 2011.
Robert Sargis,
Reports Clearance Officer.
mstockstill on DSKH9S0YB1PROD with NOTICES
[FR Doc. 2011–2798 Filed 2–8–11; 8:45 am]
BILLING CODE 4184–01–M
VerDate Mar<15>2010
17:08 Feb 08, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–P–0394] (formerly
Docket No. 2005P–0168)
Determination That DECASPRAY
(Dexamethasone) Topical Aerosol,
0.04%, and AEROSEB-DEX
(Dexamethasone) Topical Aerosol,
0.01%, 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) has determined
that DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%, and AEROSEBDEX (dexamethasone) Topical Aerosol,
0.01%, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
dexamethasone topical aerosol, 0.04%
and 0.01%, if all other legal and
regulatory requirements are met.
However, in considering whether to file
an ANDA for dexamethasone topical
aerosol, 0.04% and 0.01%, future
applicants are advised that they may not
be able to obtain DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol,
0.01%, for bioequivalence testing
because the products have not been
commercially available for a number of
years. An ANDA applicant who is
unable to obtain DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol,
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
0.01%, for bioequivalence testing
should contact the Office of Generic
Drugs for a determination of what is
necessary to show bioavailability and
same therapeutic effect.
FOR FURTHER INFORMATION CONTACT:
Janice Weiner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304,
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 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
E:\FR\FM\09FEN1.SGM
09FEN1
mstockstill on DSKH9S0YB1PROD with NOTICES
7220
Federal Register / Vol. 76, No. 27 / Wednesday, February 9, 2011 / Notices
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 that has been voluntarily
withdrawn from sale was withdrawn for
reasons of safety or effectiveness. This
determination may be made at any time
after the drug has been voluntarily
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.
AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, is the subject of
ANDA 83–296, held by Allergan Herbert
(Allergan) and initially approved on
June 15, 1973. AEROSEB-DEX is
indicated for relief of the inflammatory
and pruritic manifestations of
corticosteroid-responsive dermatoses.
In its June 1997 annual report,
Allergan notified FDA that AEROSEBDEX (dexamethasone) Topical Aerosol,
0.01%, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In a letter
dated August 28, 1998, Allergan
requested withdrawal of ANDA 83–296
for AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%. In the Federal
Register of June 10, 1999 (64 FR 31226),
FDA announced that it was
withdrawing approval of ANDA 83–296,
effective July 12, 1999.
Acaderm Inc., (Acaderm) submitted a
citizen petition dated April 28, 2005
(Docket No. FDA–2005–P–0394), under
21 CFR 10.30, requesting that the
Agency determine whether AEROSEBDEX (dexamethasone) Topical Aerosol,
0.01%, was withdrawn from sale for
reasons of safety or effectiveness.
Although the citizen petition did not
address DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%, that
dexamethasone topical aerosol product
has also been discontinued. On our own
initiative, we have also determined
whether DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%, was withdrawn
for safety or effectiveness reasons.
DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%, is the subject of
NDA 12–731, held by Merck & Co., Inc.
(Merck). DECASPRAY, a synthetic
adrenocortical steroid, was initially
approved on March 29, 1961, solely on
the basis of safety. The 1962
amendments to the FD&C Act require
that drugs be shown to be effective as
VerDate Mar<15>2010
17:08 Feb 08, 2011
Jkt 223001
well. To accomplish this, FDA initiated
the Drug Efficacy Study Implementation
(DESI) review to evaluate the
effectiveness of drugs that had been
previously approved on safety grounds
alone. In its DESI review of topical
corticosteroids, FDA concluded that
NDA 12–731 for dexamethasone topical
aerosol was effective for certain
indications (see 36 FR 7982, April 28,
1971), and it was labeled for relief of the
inflammatory and pruritic
manifestations of corticosteroidresponsive dermatoses.
In its annual report, Merck notified
FDA that DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In a letter dated June 25, 2002,
Merck requested withdrawal of NDA
12–731 for DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%. In the Federal Register of
August 18, 2003 (68 FR 49481), FDA
announced that it was withdrawing
approval of NDA 12–731, effective
September 17, 2003.
After considering the citizen petition
and comments submitted to the docket,
and reviewing Agency records, FDA has
determined under § 314.161 that
AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, was not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that AEROSEBDEX (dexamethasone) Topical Aerosol,
0.01%, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, from sale and
have found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
FDA has also determined under
§ 314.161 that DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%, was not withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events and 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 DECASPRAY
(dexamethasone) Topical Aerosol,
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
0.04%, and AEROSEB-DEX
(dexamethasone) Topical Aerosol,
0.01%, 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 DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%, and AEROSEB-DEX
(dexamethasone) Topical Aerosol,
0.01%, may be approved by the Agency
as long as they meet all other legal and
regulatory requirements for approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
In considering whether to file an
ANDA for this drug product, future
applicants should be advised that they
may not be able to obtain DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol,
0.01%, for bioequivalence testing
because the products have not been
commercially available for a number of
years. An ANDA applicant who is
unable to obtain DECASPRAY
(dexamethasone) Topical Aerosol,
0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol,
0.01%, for bioequivalence testing
should contact the Office of Generic
Drugs for a determination of what
showing is necessary to satisfy the
requirements of section 505(j)(2)(A)(iv)
of the FD&C Act. If an ANDA is
approved without a showing of
bioequivalence, the approved product
will not be considered therapeutically
equivalent to the reference listed drug,
i.e., granted an AB rating, in the Orange
Book.
Dated: February 3, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–2890 Filed 2–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0063]
Medical Device Innovation Initiative;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\09FEN1.SGM
Notice.
09FEN1
]]>Agencies
[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Notices]
[Pages 7219-7220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-P-0394] (formerly Docket No. 2005P-0168)
Determination That DECASPRAY (Dexamethasone) Topical Aerosol,
0.04%, and AEROSEB-DEX (Dexamethasone) Topical Aerosol, 0.01%, 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) has determined that
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
dexamethasone topical aerosol, 0.04% and 0.01%, if all other legal and
regulatory requirements are met. However, in considering whether to
file an ANDA for dexamethasone topical aerosol, 0.04% and 0.01%, future
applicants are advised that they may not be able to obtain DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, for bioequivalence testing because the products
have not been commercially available for a number of years. An ANDA
applicant who is unable to obtain DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
for bioequivalence testing should contact the Office of Generic Drugs
for a determination of what is necessary to show bioavailability and
same therapeutic effect.
FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304, 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 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
[[Page 7220]]
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 that has been
voluntarily withdrawn from sale was withdrawn for reasons of safety or
effectiveness. This determination may be made at any time after the
drug has been voluntarily 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.
AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, is the subject
of ANDA 83-296, held by Allergan Herbert (Allergan) and initially
approved on June 15, 1973. AEROSEB-DEX is indicated for relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
In its June 1997 annual report, Allergan notified FDA that AEROSEB-
DEX (dexamethasone) Topical Aerosol, 0.01%, was being discontinued, and
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated August 28, 1998, Allergan
requested withdrawal of ANDA 83-296 for AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%. In the Federal Register of June 10, 1999 (64 FR
31226), FDA announced that it was withdrawing approval of ANDA 83-296,
effective July 12, 1999.
Acaderm Inc., (Acaderm) submitted a citizen petition dated April
28, 2005 (Docket No. FDA-2005-P-0394), under 21 CFR 10.30, requesting
that the Agency determine whether AEROSEB-DEX (dexamethasone) Topical
Aerosol, 0.01%, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, that dexamethasone topical
aerosol product has also been discontinued. On our own initiative, we
have also determined whether DECASPRAY (dexamethasone) Topical Aerosol,
0.04%, was withdrawn for safety or effectiveness reasons.
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, is the subject of
NDA 12-731, held by Merck & Co., Inc. (Merck). DECASPRAY, a synthetic
adrenocortical steroid, was initially approved on March 29, 1961,
solely on the basis of safety. The 1962 amendments to the FD&C Act
require that drugs be shown to be effective as well. To accomplish
this, FDA initiated the Drug Efficacy Study Implementation (DESI)
review to evaluate the effectiveness of drugs that had been previously
approved on safety grounds alone. In its DESI review of topical
corticosteroids, FDA concluded that NDA 12-731 for dexamethasone
topical aerosol was effective for certain indications (see 36 FR 7982,
April 28, 1971), and it was labeled for relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
In its annual report, Merck notified FDA that DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, was being discontinued, and FDA
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated June 25, 2002, Merck
requested withdrawal of NDA 12-731 for DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%. In the Federal Register of August 18, 2003 (68
FR 49481), FDA announced that it was withdrawing approval of NDA 12-
731, effective September 17, 2003.
After considering the citizen petition and comments submitted to
the docket, and reviewing Agency records, FDA has determined under
Sec. 314.161 that AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
was not withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, from sale and have found no
information that would indicate that this product was withdrawn from
sale for reasons of safety or effectiveness.
FDA has also determined under Sec. 314.161 that DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, was not withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events
and 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 DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, 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 DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
may be approved by the Agency as long as they meet all other legal and
regulatory requirements for approval of ANDAs. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
In considering whether to file an ANDA for this drug product,
future applicants should be advised that they may not be able to obtain
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing
because the products have not been commercially available for a number
of years. An ANDA applicant who is unable to obtain DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, for bioequivalence testing should contact the
Office of Generic Drugs for a determination of what showing is
necessary to satisfy the requirements of section 505(j)(2)(A)(iv) of
the FD&C Act. If an ANDA is approved without a showing of
bioequivalence, the approved product will not be considered
therapeutically equivalent to the reference listed drug, i.e., granted
an AB rating, in the Orange Book.
Dated: February 3, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-2890 Filed 2-8-11; 8:45 am]
BILLING CODE 4160-01-P
