Determination That DEMADEX (Torsemide) Injection, 20 Milligrams/2 Milliliter (10 Milligrams/Milliliter) and 50 Milligrams/5 Milliliter (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 41437-41438 [E9-19641]
Download as PDF
Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
warranted, to provide advice on these
issues. The draft meeting agenda and
other information about SACGHS,
including information about access to
the Web cast, will be available at the
following Web site: https://
oba.od.nih.gov/SACGHS/
sacghs_meetings.html.
Dated: August 10, 2009.
Jennifer Spaeth,
Director, NIH Office of Federal Advisory
Committee Policy.
[FR Doc. E9–19584 Filed 8–14–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY: Department of Health and
Human Services.
ACTION: Notice: correction.
Food and Drug Administration
[Docket No. FDA–2008–P–0443]
SUMMARY: The Department of Health and
Human Services (HHS) published a
document in the Federal Register of
July 17, 2009, requesting OMB
reauthorization of the form
‘‘Sterilization of Persons in Federally
Assisted Family Planning Projects.’’ The
document contained an incorrect
citation to the HHS sterilization
regulations; incorrectly identified the
Office of Population Affairs (OPA),
rather than the Public Health Service
(PHS), as the agency within HHS that
administers programs of health services
which are supported by Federal
financial assistance and which are
required to obtain informed consent
from persons undergoing sterilizations;
incorrectly described the form that is
required to be used to obtain informed
consent; and incorrectly referred to the
regulations to which the consent form is
appended as OPA regulations rather
than PHS regulations.
FOR FURTHER INFORMATION CONTACT:
Sherette Funn-Coleman, 202–690–5683.
Corrections:
In the Federal Register of July 17,
2009, in FR Doc. OS–0937–0166, on
page 34757, in the second column,
correct the citation to the sterilization
regulations to read:
Proposed Project: HHS 42 CFR part
50, subpart B; Sterilization of Persons in
Federally Assisted Family Planning
Projects—
In the third column, correct the
‘‘Abstract’’ related to the consent form
to read as follows:
The consent form solicits information
to assure voluntary and informed
consent to persons undergoing
17:55 Aug 14, 2009
Jkt 217001
Dated: August 7, 2009.
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–19566 Filed 8–14–09; 8:45 am]
BILLING CODE 4150–34–P
Sterilization of Persons in Federally
Assisted Family Planning Projects
(July 17, 2009); Correction
VerDate Nov<24>2008
sterilization in programs of health
services which are supported by Federal
financial assistance administered by the
Public Health Service (PHS). The form
provides additional procedural
protections to individuals undergoing
sterilization. In order to obtain informed
consent, the regulation requires that
programs use either the form that is
appended to the PHS regulation or
another consent form approved by the
Secretary.
Determination That DEMADEX
(Torsemide) Injection, 20 Milligrams/2
Milliliter (10 Milligrams/Milliliter) and 50
Milligrams/5 Milliliter (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) is announcing its
determination that DEMADEX
(torsemide) injection, 20 milligrams
(mg)/2 milliliter (mL) (10 mg/mL) and
50 mg/5 mL (10 mg/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 torsemide
injection, 20 mg/2mL (10 mg/mL) and
50 mg/5 mL (10 mg/mL), if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6312,
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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
41437
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.
PharmaForce, Inc., submitted a citizen
petition dated August 5, 2008 (Docket
No. FDA–2008–P–0443), under 21 CFR
10.30 requesting that the agency
determine whether DEMADEX
(torsemide) injection, 20 mg/2 mL (10
mg/mL) and 50 mg/5 mL (10 mg/mL),
was withdrawn from sale for reasons of
safety or effectiveness. DEMADEX
(torsemide) injection is the subject of
NDA 20–137, held by Roche
Pharmaceuticals (Roche) and was
initially approved on August 23, 1993.
DEMADEX is indicated for the
treatment of edema associated with
congestive heart failure, renal disease,
or hepatic disease. Roche notified FDA
on June 16, 2008, that it was no longer
marketing DEMADEX (torsemide)
injection, 20 mg/2 mL (10 mg/mL) and
50 mg/5 mL (10 mg/mL), and the drug
product was moved to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
FDA has reviewed its records and,
under § 314.161, has determined that
DEMADEX (torsemide) injection, 20 mg/
2 mL (10 mg/mL) and 50 mg/5 mL (10
E:\FR\FM\17AUN1.SGM
17AUN1
41438
Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices
mg/mL), was not withdrawn from sale
for reasons of safety or effectiveness.
The petitioner identified no data or
other information suggesting that
DEMADEX (torsemide) injection, 20 mg/
2 mL (10 mg/mL) and 50 mg/5 mL (10
mg/mL), was withdrawn for reasons of
safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
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 DEMADEX
(torsemide) injection, 20 mg/2 mL (10
mg/mL) and 50 mg/5 mL (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 DEMADEX (torsemide) injection, 20
mg/2 mL (10 mg/mL) and 50 mg/5 mL
(10 mg/mL), may be approved by the
agency if all other legal and regulatory
requirements for the approval of ANDAs
are met. 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: August 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19641 Filed 8–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0268]
Draft Guidance for Industry: Labeling
of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration; Availability;
Agency Information Collection
Activities; Proposed Collection;
Comment Request
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document entitled ‘‘Guidance for
Industry: Labeling of Certain Beers
Subject to the Labeling Jurisdiction of
the Food and Drug Administration.’’
This guidance, when finalized, will
VerDate Nov<24>2008
17:55 Aug 14, 2009
Jkt 217001
provide industry with information on
how to label beers that are subject to
FDA’s labeling laws and regulations.
This draft guidance is being issued in
light of the recent ruling by the Alcohol
and Tobacco Tax and Trade Bureau
(TTB) (formerly The Bureau of Alcohol,
Tobacco, and Firearms (ATF)) clarifying
that certain beers do not meet the
definition of a ‘‘malt beverage’’ under
the Federal Alcohol Administration Act
(FAA Act). Because these beers are not
subject to the labeling provisions of the
FAA Act, they are subject to the labeling
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and the
Fair Packaging and Labeling Act (FPLA).
FDA, in this draft guidance, also
reminds manufacturers that the labeling
of wine beverages containing less than
7 percent alcohol by volume, such as
wine coolers, diluted wine beverages,
dealcoholized or partially dealcoholized
wine and ciders, is also subject to FDA
labeling requirements. FDA is also
announcing an opportunity for public
comment on the proposed collection of
certain information by the agency.
DATES: Submit written or electronic
comments on the draft guidance at any
time. Submit written or electronic
comments on the proposed collection of
information by October 16, 2009.
ADDRESSES: Submit written comments
on this draft guidance, including
comments regarding the proposed
collection of information, to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
on the draft guidance, including
comments regarding the proposed
collection of information, to https://
www.regulations.gov. Submit written
requests for single copies of the draft
guidance to Office of Nutrition, Labeling
and Dietary Supplements, Center for
Food Safety and Applied Nutrition
(HFS–800), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
Loretta A. Carey, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740,
301–436–2371.
With regard to the proposed collection
of information: Jonna Capezzuto,
Office of Information Management
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
(HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–
3794.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
the draft guidance entitled ‘‘Guidance
for Industry: Labeling of Certain Beers
Subject to the Labeling Jurisdiction of
the Food and Drug Administration.’’
This guidance, when finalized, will
provide industry with information on
how to label beers that are subject to
FDA’s labeling laws and regulations.
FDA, in this draft guidance, also
reminds manufacturers that the labeling
of wine beverages containing less than
7 percent alcohol by volume, such as
wine coolers, diluted wine beverages,
dealcoholized or partially dealcoholized
wine and ciders, is also subject to FDA
labeling requirements (Ref. 1).
As reflected in the 1987
Memorandum of Understanding
between FDA and TTB’s predecessor
agency, the ATF (Ref. 2), TTB is
responsible for the issuance and
enforcement of regulations with respect
to the labeling of distilled spirits, wines,
and malt beverages under the FAA Act.
TTB recently clarified that certain
beers, which are not made from both
malted barley and hops but are instead
made from substitutes for malted barley
(such as sorghum, rice or wheat), or are
made without hops do not meet the
definition of a malt beverage under the
FAA Act (see TTB Ruling 2008–3) (Ref.
3). TTB stated in its ruling that such
products (other than sake, which is
classified as a wine under the FAA Act)
are not subject to the labeling,
advertising, and other provisions of the
TTB regulations issued under the FAA
Act. Therefore, these beers are subject to
the labeling requirements under FDA’s
laws and regulations. However, as
explained in the TTB ruling, some TTB
labeling requirements such as the
Government Health Warning Statement
under the Alcoholic Beverage Labeling
Act and certain marking requirements
under the Internal Revenue Code
continue to apply to these products.
This draft guidance is intended to
assist manufacturers in labeling beers
that are subject to FDA’s labeling laws
and regulations. In general, FDA
requires that food products under its
labeling jurisdiction be truthfully and
informatively labeled in accordance
with the FD&C Act and the FPLA, and
FDA’s implementing regulations. These
FDA labeling requirements are
explained in the draft guidance
document.
E:\FR\FM\17AUN1.SGM
17AUN1
Agencies
[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41437-41438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19641]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0443]
Determination That DEMADEX (Torsemide) Injection, 20 Milligrams/2
Milliliter (10 Milligrams/Milliliter) and 50 Milligrams/5 Milliliter
(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) is announcing its
determination that DEMADEX (torsemide) injection, 20 milligrams (mg)/2
milliliter (mL) (10 mg/mL) and 50 mg/5 mL (10 mg/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
torsemide injection, 20 mg/2mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6312, 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 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.
PharmaForce, Inc., submitted a citizen petition dated August 5,
2008 (Docket No. FDA-2008-P-0443), under 21 CFR 10.30 requesting that
the agency determine whether DEMADEX (torsemide) injection, 20 mg/2 mL
(10 mg/mL) and 50 mg/5 mL (10 mg/mL), was withdrawn from sale for
reasons of safety or effectiveness. DEMADEX (torsemide) injection is
the subject of NDA 20-137, held by Roche Pharmaceuticals (Roche) and
was initially approved on August 23, 1993. DEMADEX is indicated for the
treatment of edema associated with congestive heart failure, renal
disease, or hepatic disease. Roche notified FDA on June 16, 2008, that
it was no longer marketing DEMADEX (torsemide) injection, 20 mg/2 mL
(10 mg/mL) and 50 mg/5 mL (10 mg/mL), and the drug product was moved to
the ``Discontinued Drug Product List'' section of the Orange Book.
FDA has reviewed its records and, under Sec. 314.161, has
determined that DEMADEX (torsemide) injection, 20 mg/2 mL (10 mg/mL)
and 50 mg/5 mL (10
[[Page 41438]]
mg/mL), was not withdrawn from sale for reasons of safety or
effectiveness. The petitioner identified no data or other information
suggesting that DEMADEX (torsemide) injection, 20 mg/2 mL (10 mg/mL)
and 50 mg/5 mL (10 mg/mL), was withdrawn for reasons of safety or
effectiveness. FDA has independently evaluated relevant literature and
data for possible postmarketing adverse events and has 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 DEMADEX (torsemide) injection, 20 mg/2 mL (10 mg/
mL) and 50 mg/5 mL (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 DEMADEX (torsemide) injection, 20
mg/2 mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), may be approved by the
agency if all other legal and regulatory requirements for the approval
of ANDAs are met. 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: August 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19641 Filed 8-14-09; 8:45 am]
BILLING CODE 4160-01-S