Notice: Memorandums of Understanding: Food and Drug Administration and Regents of The University of California

Federal Register / Vol. 73, No.
6 / Wednesday, January 9, 2008 / Notices 1619
DEPARTMENT OF HEALTH AND Therapeutic Equivalence Evaluations,’’ versions of that strength are currently
HUMAN SERVICES which is generally known as the being marketed.
‘‘Orange Book.’’ Under FDA regulations, We have reviewed our records and
Food and Drug Administration drugs are removed from the list if the determined that INDERAL Tablets, 10
[Docket No. 2007P–0295] agency withdraws or suspends approval mg, 20 mg, and 90 mg, were not
of the drug’s NDA or ANDA for reasons withdrawn from sale for reasons of
Determination That INDERAL of safety or effectiveness, or if FDA safety or effectiveness. We have also
(Propranolol Hydrochloride) Tablets, determines that the listed drug was independently evaluated relevant
10 Milligrams, 20 Milligrams, and 90 withdrawn from sale for reasons of literature and data for possible
Milligrams Were Not Withdrawn From safety or effectiveness (21 CFR 314.162). postmarketing adverse events and have
Sale for Reasons of Safety or Under § 314.161(a) (21 CFR found no information that would
Effectiveness 314.161(a)), the agency must determine indicate that INDERAL Tablets, 10 mg,
whether a listed drug was withdrawn 20 mg, and 90 mg, were withdrawn from
AGENCY: Food and Drug Administration, from sale for reasons of safety or sale for reasons of safety or
HHS. effectiveness: (1) Before an ANDA that effectiveness.
ACTION: Notice. refers to that listed drug may be After considering the citizen petition
approved or (2) whenever a listed drug and reviewing its records, FDA has
SUMMARY: The Food and Drug
is voluntarily withdrawn from sale, and determined that, for the reasons
Administration (FDA) has determined
ANDAs that referred to the listed drug outlined in this notice, INDERAL
that INDERAL (propranolol
have been approved. Section 314.161(d) (propranolol HCl) Tablets, 10 mg, 20
hydrochloride (HCl)) Tablets, 10
provides that if FDA determines that the mg, and 90 mg, were not withdrawn
milligrams (mg), 20 mg, and 90 mg,
listed drug was removed from sale for from sale for reasons of safety or
were not withdrawn from sale for
safety or effectiveness reasons, the effectiveness. Accordingly, the agency
reasons of safety or effectiveness. This
agency will initiate proceedings that will continue to list INDERAL
determination means that FDA will not
could result in the withdrawal of (propranolol HCl) Tablets, 10 mg, 20
begin procedures to withdraw approval
approval of the ANDAs that refer to the mg, and 90 mg, in the ‘‘Discontinued
of abbreviated new drug applications
listed drug. FDA may not approve an Drug Product List’’ section of the Orange
(ANDAs) that refer to the drug products,
ANDA that does not refer to a listed Book. The ‘‘Discontinued Drug Product
and it will allow FDA to approve
drug. List’’ delineates, among other items,
ANDAs for propranolol HCl tablets, 10
INDERAL (propranolol HCl) Tablets, drug products that have been
mg, 20 mg, and 90 mg as long as they
10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and discontinued from marketing for reasons
meet relevant legal and regulatory
90 mg, are the subject of approved NDA other than safety or effectiveness.
requirements.
16–418 held by Wyeth Pharmaceuticals, ANDAs that refer to INDERAL
FOR FURTHER INFORMATION CONTACT: Inc. (Wyeth). INDERAL is indicated in (propranolol HCl) Tablets, 10 mg, 20
Mary Catchings, Center for Drug the treatment of hypertension, angina mg, and 90-mg, may be approved by the
Evaluation and Research (HFD–7), Food pectoris, atrial fibrillation, myocardial agency as long as they comply with
and Drug Administration, 5600 Fishers infarction, migraine headaches, relevant legal and regulatory
Lane, Rockville, MD 20857, 301–594– essential tremors, hypertrophic requirements. If FDA determines that
2041. subaortic stenosis, and labeling for this drug product should be
SUPPLEMENTARY INFORMATION: In 1984, pheochromocytoma. In tablet form, revised to meet current standards, the
Congress enacted the Drug Price INDERAL is currently available in 40-, agency will advise ANDA applicants to
Competition and Patent Term 60-, and 80-mg strengths. Wyeth submit such labeling.
Restoration Act of 1984 (Public Law 98– discontinued marketing the tablet form Dated: January 2, 2008.
417) (the 1984 amendments), which in the 10-, 20-, and 90-mg strengths, and Jeffrey Shuren,
authorized the approval of duplicate those products were moved from the Assistant Commissioner for Policy.
versions of drug products approved prescription drug product list to the
[FR Doc. E8–190 Filed 1–8–08; 8:45 am]
under an ANDA procedure. ANDA ‘‘Discontinued Drug Product List’’
BILLING CODE 4160–01–S
sponsors must, with certain exceptions, section of the Orange Book.
show that the drug for which they are In a citizen petition dated July 20,
seeking approval contains the same 2007 (Docket No. 2007P–0295/CP1), DEPARTMENT OF HEALTH AND
active ingredient in the same strength submitted under 21 CFR 10.25(a) and HUMAN SERVICES
and dosage form as the ‘‘listed drug,’’ 10.30, Regulus Pharmaceutical
which is a version of the drug that was Consulting, Inc., requested that the Food and Drug Administration
previously approved. ANDA applicants agency determine, as described in
do not have to repeat the extensive § 314.161, whether INDERAL [FDA No. 225–07–8004]
clinical testing otherwise necessary to (propranolol HCl) Tablets, 10 mg and 20
Memorandum of Understanding
gain approval of a new drug application mg, were withdrawn from sale for
Between the Food and Drug
(NDA). The only clinical data required reasons of safety or effectiveness. The
Administration and Regents of the
in an ANDA are data to show that the petitioner has identified no data or other
University of California
drug that is the subject of the ANDA is information suggesting that INDERAL
bioequivalent to the listed drug. Tablets, 10 mg and 20 mg, were AGENCY: Food and Drug Administration,
The 1984 amendments include what withdrawn from sale as a result of safety HHS.
is now section 505(j)(7) of the Federal or effectiveness concerns. Although the
pwalker on PROD1PC71 with NOTICES
ACTION: Notice.
Food, Drug, and Cosmetic Act (21 U.S.C. citizen petition did not address the 90-
355(j)(7)), which requires FDA to mg strength, FDA must make a SUMMARY: The Food and Drug
publish a list of all approved drugs. determination regarding whether that Administration (FDA) is providing
FDA publishes this list as part of the strength was withdrawn for safety or notice of a memorandum of
‘‘Approved Drug Products With efficacy reasons because generic understanding (MOU) between FDA and
VerDate Aug<31>2005 17:53 Jan 08, 2008 Jkt 214001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1
1620 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices
the University of California, Davis extended partnerships such as the SUPPLEMENTARY INFORMATION: In
campus (UC Davis). The purpose of this Western Institute for Food Safety and accordance with 21 CFR 20.108(c),
MOU is to establish terms of Security, and the Center for Produce which states that all written agreements
collaboration between FDA and UC Safety. and MOUs between FDA and others
Davis, focused primarily but not DATES: The agreement became effective shall be published in the Federal
exclusively, in the areas of the safety December 7, 2007. Register, the agency is publishing notice
and security of foods and cosmetics, FOR FURTHER INFORMATION CONTACT: of this MOU.
animal feeds and veterinary products. Mary I. Poos, Officeof the Dated: December 26, 2007.
Beyond the collaborations in the Commissioner, Office of the Chief Jeffrey Shuren,
traditional academic programs for Medical Officer (HF–40), Food and Drug
training, research and outreach, this Assistant Commissioner for Policy.
Administration, 5600 Fishers Lane,
MOU will also include UC Davis Rockville, MD 20857, 301–827–2825. BILLING CODE 4160–01–S
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Notices 1621
EN09JA08.005</GPH>
EN09JA08.006</GPH>
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EN09JA08.008</GPH>
EN09JA08.009</GPH>
EN09JA08.010</GPH>
EN09JA08.011</GPH>
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[FR Doc. 08–30 Filed 1–8–08; 8:45 am] Place: Courtyard Marriott, 2899 Jefferson Date: February 28, 2008.
BILLING CODE 4160–01–C
Davis Highway, Arlington, VA 22202. Time: 1 p.m. to 3 p.m.
Contact Person: Mark Roltsch, PhD, Agenda: To review and evaluate grant
Scientific Review Administrator, Review applications.
Branch/DERA, National Heart, Lung, and Place: National Institutes of Health, 6701
DEPARTMENT OF HEALTH AND Blood Institute, 6701 Rockledge Drive, Room Rockledge Drive, Bethesda, MD 20892,
HUMAN SERVICES 7192, Bethesda, MD 20892–7924, 301–435– (Telephone Conference Call).
0287, roltschm@nhlbi.nih.gov. Contact Person: Keary A Cope, PhD,
National Institutes of Health Name of Committee: National Heart, Lung, Scientific Review Administrator, Review
and Blood Institute Special Emphasis Panel; Branch/DERA, National Heart, Lung, and
National Heart, Lung, and Blood Pathobiology Program Project. Blood Institute, 6701 Rockledge Drive, Room
Institute; Notice of Closed Meetings Date: February 21, 2008. 7190, Bethesda, MD 20892–7924, 301–435–
Time: 10 a.m. to 3 p.m. 2222, copeka@mail.nih.gov.
Pursuant to section 10(d) of the Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance
Federal Advisory Committee Act, as applications. Program Nos. 93.233, National Center for
amended (5 U.S.C. Appendix 2), notice Place: Four Point Sheraton BWI, 7032 Elm Sleep Disorders Research; 93.837, Heart and
is hereby given of the following Road, Baltimore, MD 21240. Vascular Diseases Research; 93.838, Lung
meetings. Contact Person: Charles Joyce, PhD, Diseases Research; 93.839, Blood Diseases
The meetings will be closed to the Scientific Review Administrator, Review and Resources Research, National Institutes
Branch/DERA, National Heart, Lung, and of Health, HHS)
public in accordance with the Blood Institute, 6701 Rockledge Drive, Room
provisions set forth in sections 7196, Bethesda, MD 20892–7924, 301–435– Dated: January 3, 2008.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 0288, cjoyce@nhlbi.nih.gov. Jennifer Spaeth,
as amended. The grant applications and Name of Committee: National Heart, Lung, Director, Office of Federal Advisory
the discussions could disclose and Blood Institute Special Emphasis Panel; Committee Policy.
confidential trade secrets or commercial Coagulation Program Project. [FR Doc. 08–41 Filed 1–8–08; 8:45 am]
property such as patentable material, Date: February 22, 2008.
BILLING CODE 4140–01–M
and personal information concerning Time: 10 a.m. to 3 p.m.
individuals associated with the grant Agenda: To review and evaluate grant
applications, the disclosure of which applications.
Place: Four Point Sheraton BWI, 7032 Elm DEPARTMENT OF HEALTH AND
would constitute a clearly unwarranted Road, Baltimore, MD 21240. HUMAN SERVICES
invasion of personal privacy. Contact Person: Charles Joyce, PhD,
Name of Committee: National Heart, Lung, Scientific Review Administrator, Review National Institutes of Health
and Blood Institute Special Emphasis Panel; Branch/DERA, National Heart, Lung, and
Patient Oriented and Career Enhancement Blood Institute, 6701 Rockledge Drive, Room National Heart, Lung, and Blood
Awards for Stem Cell Research. 7196, Bethesda, MD 20892–7924, 301–435– Institute; Notice of Closed Meetings
Date: February 20–21, 2008. 0288, cjoyce@nhlbi.nih.gov.
Time: 8 a.m. to 1 p.m. Name of Committee: National Heart, Lung, Pursuant to section 10(d) of the
Agenda: To review and evaluate grant and Blood Institute Special Emphasis Panel; Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
EN09JA08.014</GPH>
applications. Resource Related Research Project.

Notice: Memorandums of Understanding: Food and Drug Administration and Regents of The University of California

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Federal Register / Vol. 73, No.

6 / Wednesday, January 9, 2008 / Notices 1619

applications. Resource Related Research Project.

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