Sterilization of Persons in Federally Assisted Family Planning Projects (July 17, 2009); Correction, 41437 [E9-19566]
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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
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Fmt 4703
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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
]]>Agencies
[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Page 41437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19566]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Sterilization of Persons in Federally Assisted Family Planning
Projects (July 17, 2009); Correction
AGENCY: Department of Health and Human Services.
ACTION: Notice: correction.
-----------------------------------------------------------------------
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 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.
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
