Determination That SUSTIVA (Efavirenz) 300-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 5061-5062 [E7-1748]
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5061
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
No. of
Respondents
Form FDA No.
Amendments/Resubmissions
356h
Annual Frequency per
Response
306
Total Annual
Responses
11.6
Hours per
Response
3,563
Total Hours
20
Total
71,260
335,806.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirements under §§ 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c), 640.74(b)(2),
660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3 The reporting requirements under §§ 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) and (b), 660.35(a), (cg), and (i-m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.62.
4 The reporting requirements under §§ 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c),
640.56(c), 640.64(c), 640.74(a) and (b)(2), and 680.1(d) are included in the estimate under § 601.12(b)
5 The reporting requirements under §§ 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under § 601.12(c).
6 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3).
2 The
Under Table 2, the estimated
recordkeeping burden of 1 hour is based
on previous estimates for the
recordkeeping requirements associated
with the AER system.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
601.91(b)(2)(iii)
1There
1
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0052]
Determination That SUSTIVA
(Efavirenz) 300-Milligram Tablets Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
Total Annual
Records
1
Hours per
Record
1
Total Hours
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1741 Filed 2–1–07; 8:45 am]
ACTION:
Annual Frequency per
Recordkeeping
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that SUSTIVA (efavirenz) 300-milligram
(mg) tablets were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for efavirenz
300-mg tablets, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
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 typically a version of the drug
that was previously approved under a
new drug application (NDA). Sponsors
of ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of an 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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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 (§ 314.162 (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.
In a citizen petition dated January 24,
2006 (Docket No. 2006P–0052/CP1),
submitted under 21 CFR 10.30, Robert
W. Pollock of Lachman Consultant
Services, Inc., requested that the agency
determine whether SUSTIVA (efavirenz)
300-mg tablets were withdrawn from
sale for reasons of safety or
effectiveness. SUSTIVA (efavirenz) is
approved for the treatment of human
immunodeficiency virus (HIV) type 1
infections in combination with other
antiretroviral agents. SUSTIVA
(efavirenz) 300-mg tablets are the
subject of NDA 21–360 held by BristolMyers Squibb Pharma Company (BMS).
FDA approved the NDA for SUSTIVA
(efavirenz) 300-mg tablets on February
1, 2002.
After considering the citizen petition
and reviewing agency records, FDA has
determined that SUSTIVA (efavirenz)
E:\FR\FM\02FEN1.SGM
02FEN1
5062
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
300-mg tablets were not withdrawn
from sale for reasons of safety or
effectiveness. To date, BMS has never
marketed SUSTIVA (efavirenz) 300-mg
tablets. In previous instances (see, e.g.,
67 FR 79640, December 30, 2002
(addressing a relisting request for
Diazepam Autoinjector)), the agency has
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
The petitioner identified no data or
other information suggesting that
SUSTIVA (efavirenz) 300-mg tablets
were withdrawn from sale as a result of
safety or effectiveness concerns. FDA
has reviewed its files for records
concerning the withdrawal of SUSTIVA
(efavirenz) 300-mg tablets. There is no
indication that the decision not to
market SUSTIVA (efavirenz) 300-mg
tablets commercially is a function of
safety or effectiveness concerns, and no
information has been submitted to the
docket concerning the reasons for which
SUSTIVA (efavirenz) 300-mg tablets
were withdrawn from sale. FDA’s
independent evaluation of relevant
information has uncovered nothing that
would indicate that SUSTIVA
(efavirenz) 300-mg tablets were
withdrawn from sale for reasons of
safety or effectiveness.
For the reasons outlined in this
document, FDA has determined that
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
SUSTIVA (efavirenz) 300-mg tablets
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the agency will continue
to list SUSTIVA (efavirenz) 300-mg
tablets 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 and effectiveness.
ANDAs that refer to SUSTIVA
(efavirenz) 300-mg tablets may be
approved by the agency, as long as they
meet all relevant legal and regulatory
requirements for approval of ANDAs.
Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1748 Filed 2–1–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
FDA 225–05–6001
Memorandum of Understanding
Between the Food and Drug
Administration, Duke University and
Duke University Health System, Inc.
AGENCY:
Food and Drug Administration,
Frm 00065
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA,
Duke University (DU) and Duke
University Health System, Inc. (DUHS).
The purpose of the MOU is to establish
the terms of collaboration between FDA,
DU and DUHS to support shared
interests and will begin with an
initiative entitled: The FDA, DU and
DUMC Elective Program.
The agreement became effective
September 18, 2006.
DATES:
FOR FURTHER INFORMATION CONTACT:
Nancy L. Pluhowski, Center for Devices
and Radiological Health (HFZ–1), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–827–2890.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
HHS.
PO 00000
ACTION:
Fmt 4703
Sfmt 4703
E:\FR\FM\02FEN1.SGM
02FEN1
]]>Agencies
[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5061-5062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1748]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0052]
Determination That SUSTIVA (Efavirenz) 300-Milligram Tablets 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
SUSTIVA (efavirenz) 300-milligram (mg) tablets were not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
efavirenz 300-mg tablets, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, 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
typically a version of the drug that was previously approved under a
new drug application (NDA). Sponsors of ANDAs do not have to repeat the
extensive clinical testing otherwise necessary to gain approval of an
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
(Sec. 314.162 (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.
In a citizen petition dated January 24, 2006 (Docket No. 2006P-
0052/CP1), submitted under 21 CFR 10.30, Robert W. Pollock of Lachman
Consultant Services, Inc., requested that the agency determine whether
SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons
of safety or effectiveness. SUSTIVA (efavirenz) is approved for the
treatment of human immunodeficiency virus (HIV) type 1 infections in
combination with other antiretroviral agents. SUSTIVA (efavirenz) 300-
mg tablets are the subject of NDA 21-360 held by Bristol-Myers Squibb
Pharma Company (BMS). FDA approved the NDA for SUSTIVA (efavirenz) 300-
mg tablets on February 1, 2002.
After considering the citizen petition and reviewing agency
records, FDA has determined that SUSTIVA (efavirenz)
[[Page 5062]]
300-mg tablets were not withdrawn from sale for reasons of safety or
effectiveness. To date, BMS has never marketed SUSTIVA (efavirenz) 300-
mg tablets. In previous instances (see, e.g., 67 FR 79640, December 30,
2002 (addressing a relisting request for Diazepam Autoinjector)), the
agency has determined that, for purposes of Sec. Sec. 314.161 and
314.162, never marketing an approved drug product is equivalent to
withdrawing the drug from sale.
The petitioner identified no data or other information suggesting
that SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale as a
result of safety or effectiveness concerns. FDA has reviewed its files
for records concerning the withdrawal of SUSTIVA (efavirenz) 300-mg
tablets. There is no indication that the decision not to market SUSTIVA
(efavirenz) 300-mg tablets commercially is a function of safety or
effectiveness concerns, and no information has been submitted to the
docket concerning the reasons for which SUSTIVA (efavirenz) 300-mg
tablets were withdrawn from sale. FDA's independent evaluation of
relevant information has uncovered nothing that would indicate that
SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons
of safety or effectiveness.
For the reasons outlined in this document, FDA has determined that
SUSTIVA (efavirenz) 300-mg tablets were not withdrawn from sale for
reasons of safety or effectiveness. Accordingly, the agency will
continue to list SUSTIVA (efavirenz) 300-mg tablets 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 and effectiveness. ANDAs that refer to SUSTIVA (efavirenz)
300-mg tablets may be approved by the agency, as long as they meet all
relevant legal and regulatory requirements for approval of ANDAs.
Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1748 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-S
