Memorandum of Understanding Between the Food and Drug Administration and Regents of the University of California, 1619-1630 [08-30]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007P–0295]
Determination That INDERAL
(Propranolol Hydrochloride) Tablets,
10 Milligrams, 20 Milligrams, and 90
Milligrams Were Not Withdrawn From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 INDERAL (propranolol
hydrochloride (HCl)) Tablets, 10
milligrams (mg), 20 mg, and 90 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to the drug products,
and it will allow FDA to approve
ANDAs for propranolol HCl tablets, 10
mg, 20 mg, and 90 mg as long as they
meet relevant legal and regulatory
requirements.
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.
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. 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
pwalker on PROD1PC71 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
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 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) (21 CFR
314.161(a)), the agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved or (2) whenever a listed drug
is voluntarily withdrawn from sale, and
ANDAs that referred to the listed drug
have been approved. Section 314.161(d)
provides that if FDA determines that the
listed drug was removed from sale for
safety or effectiveness reasons, the
agency will initiate proceedings that
could result in the withdrawal of
approval of the ANDAs that refer to the
listed drug. FDA may not approve an
ANDA that does not refer to a listed
drug.
INDERAL (propranolol HCl) Tablets,
10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and
90 mg, are the subject of approved NDA
16–418 held by Wyeth Pharmaceuticals,
Inc. (Wyeth). INDERAL is indicated in
the treatment of hypertension, angina
pectoris, atrial fibrillation, myocardial
infarction, migraine headaches,
essential tremors, hypertrophic
subaortic stenosis, and
pheochromocytoma. In tablet form,
INDERAL is currently available in 40-,
60-, and 80-mg strengths. Wyeth
discontinued marketing the tablet form
in the 10-, 20-, and 90-mg strengths, and
those products were moved from the
prescription drug product list to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
In a citizen petition dated July 20,
2007 (Docket No. 2007P–0295/CP1),
submitted under 21 CFR 10.25(a) and
10.30, Regulus Pharmaceutical
Consulting, Inc., requested that the
agency determine, as described in
§ 314.161, whether INDERAL
(propranolol HCl) Tablets, 10 mg and 20
mg, were withdrawn from sale for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that INDERAL
Tablets, 10 mg and 20 mg, were
withdrawn from sale as a result of safety
or effectiveness concerns. Although the
citizen petition did not address the 90mg strength, FDA must make a
determination regarding whether that
strength was withdrawn for safety or
efficacy reasons because generic
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
1619
versions of that strength are currently
being marketed.
We have reviewed our records and
determined that INDERAL Tablets, 10
mg, 20 mg, and 90 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that INDERAL Tablets, 10 mg,
20 mg, and 90 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing its records, FDA has
determined that, for the reasons
outlined in this notice, INDERAL
(propranolol HCl) Tablets, 10 mg, 20
mg, and 90 mg, were not withdrawn
from sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list INDERAL
(propranolol HCl) Tablets, 10 mg, 20
mg, and 90 mg, 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 INDERAL
(propranolol HCl) Tablets, 10 mg, 20
mg, and 90-mg, may be approved by the
agency as long as they comply with
relevant legal and regulatory
requirements. 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: January 2, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–190 Filed 1–8–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA No. 225–07–8004]
Memorandum of Understanding
Between the Food and Drug
Administration and Regents of the
University of California
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
E:\FR\FM\09JAN1.SGM
09JAN1
1620
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
the University of California, Davis
campus (UC Davis). The purpose of this
MOU is to establish terms of
collaboration between FDA and UC
Davis, focused primarily but not
exclusively, in the areas of the safety
and security of foods and cosmetics,
animal feeds and veterinary products.
Beyond the collaborations in the
traditional academic programs for
training, research and outreach, this
MOU will also include UC Davis
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
extended partnerships such as the
Western Institute for Food Safety and
Security, and the Center for Produce
Safety.
DATES: The agreement became effective
December 7, 2007.
FOR FURTHER INFORMATION CONTACT:
Mary I. Poos, Officeof the
Commissioner, Office of the Chief
Medical Officer (HF–40), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–2825.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
E:\FR\FM\09JAN1.SGM
09JAN1
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
1621
EN09JA08.005</GPH>
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
VerDate Aug<31>2005
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
EN09JA08.006</GPH>
pwalker on PROD1PC71 with NOTICES
1622
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
1623
EN09JA08.007</GPH>
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
VerDate Aug<31>2005
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
EN09JA08.008</GPH>
pwalker on PROD1PC71 with NOTICES
1624
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
1625
EN09JA08.009</GPH>
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
VerDate Aug<31>2005
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
EN09JA08.010</GPH>
pwalker on PROD1PC71 with NOTICES
1626
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
1627
EN09JA08.011</GPH>
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
VerDate Aug<31>2005
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
EN09JA08.012</GPH>
pwalker on PROD1PC71 with NOTICES
1628
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4725
E:\FR\FM\09JAN1.SGM
09JAN1
1629
EN09JA08.013</GPH>
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
1630
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
pwalker on PROD1PC71 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Patient Oriented and Career Enhancement
Awards for Stem Cell Research.
Date: February 20–21, 2008.
Time: 8 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Aug<31>2005
17:53 Jan 08, 2008
Jkt 214001
Place: Courtyard Marriott, 2899 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: Mark Roltsch, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7192, Bethesda, MD 20892–7924, 301–435–
0287, roltschm@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Pathobiology Program Project.
Date: February 21, 2008.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Four Point Sheraton BWI, 7032 Elm
Road, Baltimore, MD 21240.
Contact Person: Charles Joyce, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892–7924, 301–435–
0288, cjoyce@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Coagulation Program Project.
Date: February 22, 2008.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Four Point Sheraton BWI, 7032 Elm
Road, Baltimore, MD 21240.
Contact Person: Charles Joyce, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892–7924, 301–435–
0288, cjoyce@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Resource Related Research Project.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Date: February 28, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Keary A Cope, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7190, Bethesda, MD 20892–7924, 301–435–
2222, copeka@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: January 3, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 08–41 Filed 1–8–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
E:\FR\FM\09JAN1.SGM
09JAN1
EN09JA08.014</GPH>
[FR Doc. 08–30 Filed 1–8–08; 8:45 am]
]]>Agencies
[Federal Register Volume 73, Number 6 (Wednesday, January 9, 2008)]
[Notices]
[Pages 1619-1630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-30]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA No. 225-07-8004]
Memorandum of Understanding Between the Food and Drug
Administration and Regents of the University of California
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and
[[Page 1620]]
the University of California, Davis campus (UC Davis). The purpose of
this MOU is to establish terms of collaboration between FDA and UC
Davis, focused primarily but not exclusively, in the areas of the
safety and security of foods and cosmetics, animal feeds and veterinary
products. Beyond the collaborations in the traditional academic
programs for training, research and outreach, this MOU will also
include UC Davis extended partnerships such as the Western Institute
for Food Safety and Security, and the Center for Produce Safety.
DATES: The agreement became effective December 7, 2007.
FOR FURTHER INFORMATION CONTACT: Mary I. Poos, Officeof the
Commissioner, Office of the Chief Medical Officer (HF-40), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2825.
SUPPLEMENTARY INFORMATION: 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.
Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S
[[Page 1621]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.005
[[Page 1622]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.006
[[Page 1623]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.007
[[Page 1624]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.008
[[Page 1625]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.009
[[Page 1626]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.010
[[Page 1627]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.011
[[Page 1628]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.012
[[Page 1629]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.013
[[Page 1630]]
[GRAPHIC] [TIFF OMITTED] TN09JA08.014
[FR Doc. 08-30 Filed 1-8-08; 8:45 am]
BILLING CODE 4160-01-C
