Determination That CEFOTAN (Cefotetan Disodium For Injection), Equivalent 1 Gram Base/Vial and 2 Grams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 31585-31586 [E7-10959]
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31585
Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL ONE-TIME REPORTING BURDEN1—Continued
No. of
Respondents
Claim type
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Total
rwilkins on PROD1PC63 with NOTICES
1 There
189,428
are no capital costs associated with this collection of information.
Dietary supplement manufacturers
will only need to collect information to
substantiate their product’s nutritional
deficiency, structure/function, or
general well-being claim if they chose to
place a claim on their product’s label.
Gathering evidence on their product’s
claim is a one time burden; they collect
the necessary substantiating information
for their product as required by section
403(r)(6) of the act.
The standard discussed in the
guidance for substantiation of a claim
on the labeling of a dietary supplement
is consistent with standards set by the
Federal Trade Commission for dietary
supplements and other health related
products that the claim be based on
competent and reliable scientific
evidence. This evidence standard is
broad enough that some dietary
supplement manufacturers may only
need to collect peer-reviewed scientific
journal articles to substantiate their
claims; other dietary supplement
manufacturers whose products have
properties that are less well documented
may have to conduct studies to build a
body of evidence to support their
claims. It is unlikely that a dietary
supplement manufacturer will attempt
to make a claim when the cost of
obtaining the evidence to support the
claim outweighs the benefits of having
the claim on the product’s label. It is
likely that manufacturers will seek
substantiation for their claims in the
scientific literature.
The time it takes to assemble the
necessary scientific information to
support their claims depends on the
product and the claimed benefits. If the
product is one of several on the market
making a particular claim for which
there is adequate publicly available and
widely established evidence supporting
the claim, then the time to gather
supporting data will be minimal; if the
product is the first of its kind to make
a particular claim or the evidence
supporting the claim is less publicly
available or not widely established, then
gathering the appropriate scientific
evidence to substantiate the claim will
be more time consuming.
FDA assumes that it will take 44
hours to assemble information needed
to substantiate a claim on a particular
dietary supplement when the claim is
widely known and established. We
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20:59 Jun 06, 2007
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increased this estimated burden from 1
hour per claim to 44 hours per claim
based on information received from
industry, as noted in our response to
comment 1. FDA believes it will take
closer to 120 hours to assemble
supporting scientific information when
the claim is novel or when the claim is
pre-existing but the scientific
underpinnings of the claim are not
widely established. These are claims
that may be based on emerging science,
where conducting literature searches
and understanding the literature takes
time. It is also possible that references
for claims made for some dietary
ingredients or dietary supplements may
primarily be found in foreign journals
and in foreign languages or in the older,
classical literature where it is not
available on computerized literature
databases or in the major scientific
reference databases, such as the
National Library of Medicine’s literature
database, all of which increases the time
of obtaining substantiation.
In the final rule on statements made
for dietary supplements concerning the
effect of the product on the structure or
function of the body (structure/function
final rule (65 FR 1000, January 6, 2000)),
FDA estimated that there were 29,000
dietary supplement products marketed
in the United States (65 FR 1000 at
1045). Assuming that the flow of new
products is 10 percent per year, then
2,900 new dietary supplement products
will come on the market each year. The
structure/function final rule estimated
that about 69 percent of dietary
supplements have a claim on their
labels, most probably a structure/
function claim (65 FR 1000 at 1046).
Therefore, we assume that supplement
manufacturers will need time to
assemble the evidence to substantiate
each of the 2,001 claims (2,900 x 69
percent) made each year. If we assume
that the 2,001 claims are equally likely
to be pre-existing widely established
claims, novel claims, or pre-existing
claims that are not widely established,
then we can expect 667 of each of these
types of claims to be substantiated per
year. Table 1 of this document shows
that the annual burden hours associated
with assembling evidence for claims is
189,428 (the sum of 667 x 44 hours, 667
x 120 hours, and 667 x 120 hours).
PO 00000
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Fmt 4703
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There are no capital costs or operating
and maintenance costs associated with
this information collection.
Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–10911 Filed 6–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0201]
Determination That CEFOTAN
(Cefotetan Disodium For Injection),
Equivalent 1 Gram Base/Vial and 2
Grams Base/Vial, 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 CEFOTAN (cefotetan disodium for
injection), equivalent 1 gram (g) base/
vial and 2 g base/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for cefotetan
disodium for injection, equivalent 1 g
base/vial and 2 g base/vial, if all other
legal and regulatory requirements are
met.
Nam
Kim, Center for Drug Evaluation and
Research (HFD–7), Food and Drug
Administration, 5515 Security Lane,
Rockville, MD 20852, 301–443–5537.
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,’’
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\07JNN1.SGM
07JNN1
rwilkins on PROD1PC63 with NOTICES
31586
Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
which is typically 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 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.
CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and
2 g base/vial, is the subject of approved
NDA 50–588 held by AstraZeneca
Pharmaceuticals LP (AstraZeneca).
CEFOTAN (cefotetan disodium for
injection) is indicated for the
therapeutic treatment of urinary tract
infections, lower respiratory tract
infections, skin and skin structure
infections, gynecologic infections, intraabdominal infections, and bone and
joint infections when caused by
susceptible strains of the designated
organisms described in the labeling.
FDA approved the NDA for CEFOTAN
(cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/
vial, on December 27, 1985. Beginning
with the October 2006 update, FDA has
listed CEFOTAN (cefotetan disodium
for injection), equivalent 1 g base/vial
and 2 g base/vial, in the ‘‘Discontinued
Drug Product List’’ of the Orange Book
because AstraZeneca notified FDA that
the product was no longer marketed.
B. Braun Medical Inc., submitted a
citizen petition dated May 10, 2006
(Docket No. 2006P–0201/CP1), under 21
CFR 10.30, requesting that the agency
determine whether CEFOTAN (cefotetan
disodium for injection), equivalent 1 g
base/vial and 2 g base/vial (NDA 50–
588) was withdrawn from sale for
VerDate Aug<31>2005
20:59 Jun 06, 2007
Jkt 211001
reasons of safety or effectiveness. After
considering the citizen petition
(including comments submitted) and
reviewing agency records, FDA has
determined that CEFOTAN (cefotetan
disodium for injection), equivalent 1 g
base/vial and 2 g base/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that CEFOTAN (cefotetan
disodium for injection), equivalent 1 g
base/vial and 2 g base/vial, was
withdrawn from sale as a result of safety
or effectiveness concerns. FDA has
independently evaluated relevant
literature and data for adverse event
reports and has found no information
that would indicate that CEFOTAN
(cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/
vial, was withdrawn for reasons of
safety or effectiveness.
For the reasons outlined in this
document, FDA determines that
CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and
2 g base/vial, was not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list CEFOTAN
(cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/
vial, 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 CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and
2 g base/vial, may be approved by the
agency as long as they meet all relevant
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.
Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–10959 Filed 6–6–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M–0109, 2007M–0006,
2007M–0007, 2007M–0032, 2007M–0049,
2007M–0038, 2007M–0058, 2007M–0086,
2007M–0107, 2007M–0084, 2007M–0108]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Thinh Nguyen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4010, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31585-31586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10959]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0201]
Determination That CEFOTAN (Cefotetan Disodium For Injection),
Equivalent 1 Gram Base/Vial and 2 Grams Base/Vial, 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
CEFOTAN (cefotetan disodium for injection), equivalent 1 gram (g) base/
vial and 2 g base/vial, was not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for cefotetan disodium for
injection, equivalent 1 g base/vial and 2 g base/vial, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation
and Research (HFD-7), Food and Drug Administration, 5515 Security Lane,
Rockville, MD 20852, 301-443-5537.
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,''
[[Page 31586]]
which is typically 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 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.
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/
vial and 2 g base/vial, is the subject of approved NDA 50-588 held by
AstraZeneca Pharmaceuticals LP (AstraZeneca). CEFOTAN (cefotetan
disodium for injection) is indicated for the therapeutic treatment of
urinary tract infections, lower respiratory tract infections, skin and
skin structure infections, gynecologic infections, intra-abdominal
infections, and bone and joint infections when caused by susceptible
strains of the designated organisms described in the labeling. FDA
approved the NDA for CEFOTAN (cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/vial, on December 27, 1985.
Beginning with the October 2006 update, FDA has listed CEFOTAN
(cefotetan disodium for injection), equivalent 1 g base/vial and 2 g
base/vial, in the ``Discontinued Drug Product List'' of the Orange Book
because AstraZeneca notified FDA that the product was no longer
marketed.
B. Braun Medical Inc., submitted a citizen petition dated May 10,
2006 (Docket No. 2006P-0201/CP1), under 21 CFR 10.30, requesting that
the agency determine whether CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and 2 g base/vial (NDA 50-588) was
withdrawn from sale for reasons of safety or effectiveness. After
considering the citizen petition (including comments submitted) and
reviewing agency records, FDA has determined that CEFOTAN (cefotetan
disodium for injection), equivalent 1 g base/vial and 2 g base/vial,
was not withdrawn from sale for reasons of safety or effectiveness. The
petitioner identified no data or other information suggesting that
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial
and 2 g base/vial, was withdrawn from sale as a result of safety or
effectiveness concerns. FDA has independently evaluated relevant
literature and data for adverse event reports and has found no
information that would indicate that CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and 2 g base/vial, was withdrawn
for reasons of safety or effectiveness.
For the reasons outlined in this document, FDA determines that
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial
and 2 g base/vial, was not withdrawn from sale for reasons of safety or
effectiveness. Accordingly, the agency will continue to list CEFOTAN
(cefotetan disodium for injection), equivalent 1 g base/vial and 2 g
base/vial, 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
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial
and 2 g base/vial, may be approved by the agency as long as they meet
all relevant 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.
Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10959 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S
