Determination That PHOSLO (Calcium Acetate) 667-Milligram Tablet Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 43643-43644 [E7-15172]
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Federal Register / Vol. 72, No. 150 / Monday, August 6, 2007 / Notices
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
State of Pennsylvania Fire and Life
Safety Public Education Survey—New—
Division of Unintentional Injury,
National Center for Injury Prevention
and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
43643
departments in Pennsylvania along with
their contact information. Fire
departments will be asked to complete
a 35-item survey either on-line or by
returning a paper survey. It is expected
that 1,000 fire departments will
complete the 30 minute survey, which
is designed to collect information on the
scope and content of educational
programs and activities, training needs,
and barriers to fire and life safety
education. An initial mailing (and email if e-mail address exists) to the fire
chief of each fire department will
include a postcard describing the study
and instructing them how to submit the
survey. Fire departments that have not
completed the survey and have not
declined will be sent a reminder
postcard and will receive a follow-up
telephone call.
There are no costs to respondents
except for their time to participate in the
surveys.
Background and Brief Description
This project will involve conducting a
statewide survey of Pennsylvania fire
departments to identify current fire and
life safety education programs,
resources, and training needs. Survey
findings will be used to develop an
inventory of programs and resources,
and to inform future training programs
for fire and life safety educators in
Pennsylvania. In the United States each
year, there are approximately 400,000
residential fires, with 14,000 non-fatal
and 3,000 fatal civilian injuries. In line
with Healthy People 2010 objectives,
National Center of Injury Prevention
and Control (NCIPC) works to reduce
and eliminate non-fatal and fatal
injuries from residential fires.
The survey will be conducted with
fire departments in Pennsylvania. The
2007 National Directory of Fire Chiefs &
EMS Administrators lists all fire
ESTIMATED ANNUALIZED BURDEN HOURS
Respondents
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
(in hours)
Fire Departments—Completed survey ............................................
1,000
1
30/60
500
............................
............................
............................
500
Total ..........................................................................................
Dated: July 31, 2007.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–15218 Filed 8–3–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for calcium
acetate 667-mg tablet.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
BILLING CODE 4163–18–P
[Docket Nos. 2006P–0287 and 2006P–0399]
Determination That PHOSLO (Calcium
Acetate) 667-Milligram Tablet Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that PHOSLO (calcium acetate) 667milligram (mg) tablet, equal to 169 mg
calcium, was not withdrawn from sale
for reasons of safety or effectiveness.
VerDate Aug<31>2005
19:38 Aug 03, 2007
Jkt 211001
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
sponsors 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. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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,
drugs are withdrawn 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
E:\FR\FM\06AUN1.SGM
06AUN1
43644
Federal Register / Vol. 72, No. 150 / Monday, August 6, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
ANDA that does not refer to a listed
drug.
PHOSLO (calcium acetate) 667-mg
tablet, equal to 169 mg calcium, is the
subject of approved NDA 19–976 held
by Fresenius Medical Care (Fresenius).
PHOSLO (calcium acetate) 667-mg
tablet is indicated for the control of
hyperphosphatemia in end stage renal
failure. Fresenius’s NDA 19–976 was
approved on December 10, 1990.
Lachman Consultant Services, Inc., and
Beckloff Associates, submitted citizen
petitions dated July 14, 2006 (Docket
No. 2006P–0287/CP1) and September
27, 2006 (Docket No. 2006P–0399),
respectively, under 21 CFR 10.30,
requesting that the agency determine, as
described in § 314.161, whether
PHOSLO (calcium acetate) 667-mg
tablet was withdrawn from sale for
reasons of safety or effectiveness.
The agency has determined that
Fresenius’s PHOSLO (calcium acetate)
667-mg tablet was not withdrawn from
sale for reasons of safety or
effectiveness. FDA has reviewed its files
for records concerning the withdrawal
of PHOSLO (calcium acetate) 667-mg
tablet from sale. There is no indication
that the decision to discontinue
marketing of PHOSLO (calcium acetate)
667-mg tablet was a function of safety or
effectiveness concerns, and the
petitioner has identified no data or
information suggesting that PHOSLO
(calcium acetate) 667-mg tablet was
withdrawn for safety or effectiveness
reasons. FDA has independently
evaluated relevant literature and data
for adverse event reports and has found
no information that would indicate that
PHOSLO (calcium acetate) 667-mg
tablet was withdrawn for reasons of
safety or effectiveness.1
After considering the citizen petitions
and reviewing agency records, FDA
determines that for the reasons outlined
in this document, PHOSLO (calcium
acetate) 667-mg tablet was not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list PHOSLO
(calcium acetate) 667-mg tablet 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 PHOSLO (calcium acetate) 667-mg
1Beckloff Associates also requested that the
agency determine whether PHOSLO (calcium
acetate) 667-mg capsule was withdrawn from sale
for reasons of safety or effectiveness. Because a
capsule dosage form for this product is currently
marketed, such a determination is not necessary
(See NDA 21–160, product no. 3).
VerDate Aug<31>2005
19:38 Aug 03, 2007
Jkt 211001
tablet may be approved by the agency as
long as they meet all relevant legal and
regulatory requirements for the 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.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–15172 Filed 8–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0446]
Determination That PHENERGAN
(Promethazine Hydrochloride)
Suppositories, 12.5 Milligrams and 25
Milligrams, 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 PHENERGAN (promethazine
hydrochloride (HCl)) suppositories, 12.5
milligrams (mg) and 25 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for promethazine
HCl suppositories, 12.5 mg and 25 mg.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
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
sponsors 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. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA 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.
PHENERGAN (promethazine HCl)
suppositories, 12.5 mg and 25 mg, are
the subject of approved NDA 10–926
held by Wyeth Pharmaceuticals, Inc.
(Wyeth). PHENERGAN (promethazine
HCl) suppositories are indicated for,
among other things, certain types of
allergic reactions and sedation. Wyeth’s
NDA 10–926 was originally approved in
1958. In 1971, under the Drug Efficacy
Study Implementation (DESI), FDA
concluded that promethazine HCl rectal
suppositories were effective or probably
effective for the indications described in
the Federal Register notice published
on June 18, 1971 (DESI 6290, 36 FR
11758). In a citizen petition received
November 1, 2006 (Docket No. 2006P–
0446/CP1), submitted under 21 CFR
10.30, Taro Pharmaceuticals U.S.A.,
Inc., requested that the agency
determine, as described in § 314.161,
whether PHENERGAN (promethazine
HCl) suppositories, 12.5 mg and 25 mg,
were withdrawn from sale for reasons of
safety or effectiveness.
The agency has determined that
PHENERGAN (promethazine HCl)
suppositories, 12.5 mg and 25 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. In support of this
finding, we note that promethazine HCl
is a widely used product that has been
marketed for many decades in many
dosage forms. FDA has independently
evaluated relevant literature and data
for possible postmarketing adverse
events and has found no information
that would indicate that PHENERGAN
E:\FR\FM\06AUN1.SGM
06AUN1
]]>Agencies
[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Pages 43643-43644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006P-0287 and 2006P-0399]
Determination That PHOSLO (Calcium Acetate) 667-Milligram Tablet
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
PHOSLO (calcium acetate) 667-milligram (mg) tablet, equal to 169 mg
calcium, was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for calcium acetate 667-mg tablet.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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
sponsors 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. Sponsors of ANDAs 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, drugs are withdrawn 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
[[Page 43644]]
ANDA that does not refer to a listed drug.
PHOSLO (calcium acetate) 667-mg tablet, equal to 169 mg calcium, is
the subject of approved NDA 19-976 held by Fresenius Medical Care
(Fresenius). PHOSLO (calcium acetate) 667-mg tablet is indicated for
the control of hyperphosphatemia in end stage renal failure.
Fresenius's NDA 19-976 was approved on December 10, 1990. Lachman
Consultant Services, Inc., and Beckloff Associates, submitted citizen
petitions dated July 14, 2006 (Docket No. 2006P-0287/CP1) and September
27, 2006 (Docket No. 2006P-0399), respectively, under 21 CFR 10.30,
requesting that the agency determine, as described in Sec. 314.161,
whether PHOSLO (calcium acetate) 667-mg tablet was withdrawn from sale
for reasons of safety or effectiveness.
The agency has determined that Fresenius's PHOSLO (calcium acetate)
667-mg tablet was not withdrawn from sale for reasons of safety or
effectiveness. FDA has reviewed its files for records concerning the
withdrawal of PHOSLO (calcium acetate) 667-mg tablet from sale. There
is no indication that the decision to discontinue marketing of PHOSLO
(calcium acetate) 667-mg tablet was a function of safety or
effectiveness concerns, and the petitioner has identified no data or
information suggesting that PHOSLO (calcium acetate) 667-mg tablet was
withdrawn for safety or effectiveness reasons. FDA has independently
evaluated relevant literature and data for adverse event reports and
has found no information that would indicate that PHOSLO (calcium
acetate) 667-mg tablet was withdrawn for reasons of safety or
effectiveness.\1\
---------------------------------------------------------------------------
\1\Beckloff Associates also requested that the agency determine
whether PHOSLO (calcium acetate) 667-mg capsule was withdrawn from
sale for reasons of safety or effectiveness. Because a capsule
dosage form for this product is currently marketed, such a
determination is not necessary (See NDA 21-160, product no. 3).
---------------------------------------------------------------------------
After considering the citizen petitions and reviewing agency
records, FDA determines that for the reasons outlined in this document,
PHOSLO (calcium acetate) 667-mg tablet was not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list PHOSLO (calcium acetate) 667-mg tablet 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 PHOSLO (calcium
acetate) 667-mg tablet may be approved by the agency as long as they
meet all relevant legal and regulatory requirements for the 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.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15172 Filed 8-3-07; 8:45 am]
BILLING CODE 4160-01-S >
