Determination That DEMULEN 1/50-28 (Ethinyl Estradiol; Ethynodiol Diacetate) Tablet and Four Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 75886-75887 [2011-31146]
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75886
Federal Register / Vol. 76, No. 233 / Monday, December 5, 2011 / Notices
to which electronic medical records are
utilized within the correctional
healthcare system.
NSPHC will be a mail survey to a
prison official in the Department of
Corrections (DOC) within each of the 50
States and Federal Bureau of Prisons
(BOP) and will seek facility-level
information on the types of healthcare
services delivered and the mechanisms
used to deliver these services.
NSPHC will collect data on healthcare
services including the extent to which
services are contracted; staffing;
locations (i.e., on- or off-site) of
healthcare services and specialty
healthcare services; and the types of of
medical, dental, mental health, and
pharmaceutical services provided to
inmates. NSPHC will collect data on
intake physical and mental health
assessments practices for inmates;
credentials of staff performing
screenings; vaccinations against major
infectious diseases; and smoking
allowances. Discharge planning data
collected includes the availability of
bridge medications, Medicaid reenrollment processes, and the number
of inmates with mental illness linked to
housing prior to release. NSPHC will
also collect data on how DOCs maintain
health records including the format
(paper and/or electronic) of specific
types of health records.
Potential users of the data collected
through NSPHC are policy makers,
correctional healthcare researchers,
mental health researchers, and
corrections administrators. There is no
cost to respondents other than their time
to participate. The total estimated
annual burden is 204 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Number of
respondents
Number of
responses
per
respondent
Avg. burden
per response
(in hours)
NSPHC Questionnaire ...........
51
1
4
Respondents
Prison official in DOC or BOP (Medical/Health Researcher)
Dated: November 28, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–31108 Filed 12–2–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0826]
Determination That DEMULEN 1/50–28
(Ethinyl Estradiol; Ethynodiol
Diacetate) Tablet and Four Other 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) has determined
that the five drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
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 (Public Law 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 generally known 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 § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for reasons of
safety or effectiveness, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Application No.
Drug
Applicant
NDA 016936 ....................................
DEMULEN 1/50–28 (ethinyl estradiol; ethynodiol diacetate) Tablet,
0.05 mg; 1 mg.
DEMULEN 1/35–28 (ethinyl estradiol; ethynodiol diacetate) Tablet,
0.035 mg; 1 mg.
GD Searle, LLC, 4901 Searle
Pkwy., Skokie, IL 60077.
Do.
NDA 018160 ....................................
VerDate Mar<15>2010
16:52 Dec 02, 2011
Jkt 226001
PO 00000
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Fmt 4703
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05DEN1
75887
Federal Register / Vol. 76, No. 233 / Monday, December 5, 2011 / Notices
Application No.
Drug
NDA 018168 ....................................
NDA 019190 ....................................
DEMULEN 1/35–21 (ethinyl estradiol; ethynodiol diacetate) Tablet,
0.035 mg; 1 mg.
TRIPHASIL–28 (ethinyl estradiol; levonorgestrel) Tablet, 0.03 mg,
0.04 mg, 0.03 mg; 0.05 mg, 0.075 mg, 0.125 mg.
NDA 019192 ....................................
TRIPHASIL–21 (ethinyl estradiol; levonorgestrel) Tablet, 0.03 mg,
0.04 mg, 0.03 mg; 0.05 mg, 0.075 mg, 0.125 mg.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. Additional ANDAs that
refer to these products may also be
approved by the Agency if they comply
with relevant legal and regulatory
requirements. 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.
Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–31146 Filed 12–2–11; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0176]
jlentini on DSK4TPTVN1PROD with NOTICES
SEDASYS Computer-Assisted
Personalized Sedation System;
Ethicon Endo-Surgery, Incorporated’s
Petition for Review of the Food and
Drug Administration’s Denial of
Premarket Approval; Notice of
Cancellation of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the Medical
Devices Dispute Resolution Panel
scheduled for December 14, 2011, is
cancelled. This meeting was announced
SUMMARY:
VerDate Mar<15>2010
16:52 Dec 02, 2011
Jkt 226001
Applicant
in the Federal Register of November 21,
2011 (76 FR 71980).
FOR FURTHER INFORMATION CONTACT:
Nancy Braier, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 5454,
Silver Spring, MD 20993–0002, (301)
796–5676, FAX: (301) 847–8510, email:
nancy.braier@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The meeting of the Medical Devices
Dispute Resolution Panel of the Medical
Devices Advisory Committee scheduled
for December 14, 2011, is cancelled. On
December 14, 2011, this advisory
committee was slated to discuss the
Center for Devices and Radiological
Health’s (CDRH’s) denial of a premarket
approval application (PMA) for the
SEDASYS computer-assisted
personalized sedation system
(SEDASYS) submitted by Ethicon EndoSurgery Inc. (EES), the sponsor for
SEDASYS. This meeting has been
cancelled because EES has withdrawn
its petition for review of this denial.
On February 26, 2010, CDRH issued a
letter to EES indicating that PMA
P080009 for SEDASYS was not
approvable under § 814.44(f) (21 CFR
814.44(f)) because CDRH concluded that
the data and information offered in
support of the PMA did not provide a
reasonable assurance that the device is
safe under the conditions of use
prescribed, recommended, or suggested
in the proposed labeling, as required by
section 515(d)(2)(A) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360e(d)(2)(A)).
On March 25, 2010, EES requested
review of the not approvable letter.
Submitted in the form of a petition for
reconsideration under 21 CFR 10.33 (see
21 CFR 814.44(f)(2)), EES’s petition
stated that, in accordance with
§ 814.44(f), EES considered the not
approvable letter to be a denial of
approval of PMA P080009 under
§ 814.45 (21 CFR 814.45). In accordance
with section 515(d)(4) of the FD&C Act,
EES requested review of this denial
under section 515(g)(2) of the FD&C Act.
Subsequently, on October 26, 2010,
CDRH issued an order denying approval
of the SEDASYS PMA (Denial Order), as
PO 00000
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Fmt 4703
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Do.
Wyeth Pharmaceuticals, Inc., P.O.
Box 8299, Philadelphia, PA
19101–8299.
Do.
required by § 814.45(e)(3). On November
5, 2010, in accordance with section
515(g)(2) of the FD&C Act, FDA granted
EES’s petition for review of the Denial
Order.
FDA’s Office of the Commissioner
(OC) referred PMA P080009 and the
basis for CDRH’s Denial Order to the
Medical Devices Dispute Resolution
Panel of the Medical Devices Advisory
Committee, an advisory committee of
experts established, in part, to receive
referrals of petitions for advisory
committee review under section
515(g)(2)(B) of the FD&C Act. (See 76 FR
15321, March 21, 2011.) In the Federal
Register of November 21, 2011, FDA
announced that this advisory committee
was scheduled to meet to discuss the
clinical and scientific issues raised by
CDRH’s Denial Order on December 14,
2011.
By letter dated November 28, 2011,
EES notified OC that EES ‘‘withdraws
its request for administrative review’’ of
that order ‘‘through an independent
advisory committee under Section
515(g)(2) of the Federal Food, Drug, and
Cosmetic Act.’’ Because EES has
withdrawn its petition for review of
CDRH’s denial of approval of the
SEDASYS PMA, OC regards the matter
it initiated closed and is, accordingly,
canceling the previously mentioned
meeting of the Medical Devices Dispute
Resolution Panel scheduled for
December 14, 2011.
Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–31105 Filed 12–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the AIDS
Research Advisory Committee, NIAID.
E:\FR\FM\05DEN1.SGM
05DEN1
]]>Agencies
[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Notices]
[Pages 75886-75887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31146]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0826]
Determination That DEMULEN 1/50-28 (Ethinyl Estradiol; Ethynodiol
Diacetate) Tablet and Four Other 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) has determined that the
five drug products listed in this document were not withdrawn from sale
for reasons of safety or effectiveness. This determination means that
FDA will not begin procedures to withdraw approval of abbreviated new
drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308,
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 (Public Law 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 generally known 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) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for reasons
of safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 016936.................... DEMULEN 1/50-28 GD Searle, LLC,
(ethinyl estradiol; 4901 Searle
ethynodiol diacetate) Pkwy., Skokie,
Tablet, 0.05 mg; 1 mg. IL 60077.
NDA 018160.................... DEMULEN 1/35-28 Do.
(ethinyl estradiol;
ethynodiol diacetate)
Tablet, 0.035 mg; 1
mg.
[[Page 75887]]
NDA 018168.................... DEMULEN 1/35-21 Do.
(ethinyl estradiol;
ethynodiol diacetate)
Tablet, 0.035 mg; 1
mg.
NDA 019190.................... TRIPHASIL-28 (ethinyl Wyeth
estradiol; Pharmaceuticals
levonorgestrel) , Inc., P.O.
Tablet, 0.03 mg, 0.04 Box 8299,
mg, 0.03 mg; 0.05 mg, Philadelphia,
0.075 mg, 0.125 mg. PA 19101-8299.
NDA 019192.................... TRIPHASIL-21 (ethinyl Do.
estradiol;
levonorgestrel)
Tablet, 0.03 mg, 0.04
mg, 0.03 mg; 0.05 mg,
0.075 mg, 0.125 mg.
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. 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.
Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31146 Filed 12-2-11; 8:45 am]
BILLING CODE 4164-01-P
