Sunshine Act Meeting, 52356-52357 [E8-20989]
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52356
PLACE:
Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices
999 E Street, NW., Washington,
DC.
This meeting will be closed to
the public.
ITEMS TO BE DISCUSSED: Compliance
matters pursuant to 2 U.S.C. 437g.
Audits conducted pursuant to 2 U.S.C.
437g, 438(b), and Title 26, U.S.C.
Matters concerning participation in civil
actions or proceedings or arbitration.
Internal personnel rules and procedures
or matters affecting a particular
employee.
PERSON TO CONTACT FOR INFORMATION:
Mr. Robert Biersack, Press Officer,
Telephone: (202) 694–1220.
STATUS:
Mary W. Dove,
Secretary of the Commission.
[FR Doc. E8–20786 Filed 9–8–08; 8:45 am]
BILLING CODE 6715–01–M
FEDERAL HOUSING FINANCE
AGENCY
Establishment of a New Independent
Agency
Federal Housing Finance
Agency.
ACTION: Notice of establishment.
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AGENCY:
SUMMARY: This Notice is to announce
the establishment of a new independent
agency. Division A of the Housing and
Economic Recovery Act of 2008, Public
Law 110–289, 122 Stat. 2654 (2008),
titled the Federal Housing Finance
Regulatory Reform Act of 2008 (Act),
created the Federal Housing Finance
Agency (FHFA) as an independent
agency of the Federal Government.
FHFA was established on the date of
enactment, July 30, 2008, and the Act
provides for the abolishment of the
Office of Federal Housing Enterprise
Oversight (OFHEO) and the Federal
Housing Finance Board (FHFB) one year
after the date of enactment. These
agencies, together with the Housing and
Urban Development GovernmentSponsored Enterprise Mission Teams,
are combined to establish FHFA.
Regulations of FHFA will be found in 12
CFR chapter XII, parts 1200–1299.
FOR FURTHER INFORMATION CONTACT:
Alfred M. Pollard, General Counsel
(OFHEO), telephone (202) 414–3788 or
Christopher Curtis, General Counsel
(FHFB), telephone (202) 408–2802 (not
toll free numbers), Federal Housing
Finance Agency, Fourth Floor, 1700 G
Street, NW., Washington, DC 20552. The
telephone number for the
Telecommunications Device for the Deaf
is (800) 877–8339.
SUPPLEMENTARY INFORMATION: FHFA has
regulatory authority over the Federal
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National Mortgage Association (Fannie
Mae), the Federal Home Loan Mortgage
Corporation (Freddie Mac) and the
Federal Home Loan Banks (collectively,
the ‘‘regulated entities’’) and the Bank
System’s Office of Finance. The
establishment of FHFA strengthens the
nation’s housing finance system. This
new regulator has the authorities
necessary to enhance oversight of
Fannie Mae, Freddie Mac and the
Federal Home Loan Banks—vital
components of the nation’s secondary
mortgage markets.
FHFA was established to oversee the
prudential operations of each regulated
entity and to ensure:
• That each regulated entity operates
in a safe and sound manner, including
maintenance of adequate capital and
internal controls;
• That the operations and activities of
each regulated entity foster liquid,
efficient, competitive, and resilient
national housing finance markets
(including activities relating to
mortgages on housing for low- and
moderate-income families involving a
reasonable economic return that may be
less than the return earned on other
activities);
• That each regulated entity complies
with this title and the rules, regulations,
guidelines, and orders issued under this
title and the authorizing statutes;
• That each regulated entity carries
out its statutory mission only through
activities that are authorized under and
consistent with this title and the
authorizing statutes; and
• That the activities of each regulated
entity and the manner in which such
regulated entity is operated are
consistent with the public interest.
The authorities, powers and
responsibilities of FHFA are contained
in Titles 12 U.S.C. 1421 et seq. and 4501
et seq., as amended by Division A of
Public Law 110–289, 122 Stat. 2654
(2008).
Dated: August 30, 2008.
James B. Lockhart III,
Director, Federal Housing Finance Agency.
[FR Doc. E8–20839 Filed 9–8–08; 8:45 am]
BILLING CODE 4220–01–P
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisition of Shares of Bank or Bank
Holding Companies
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire a bank or bank
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holding company. The factors that are
considered in acting on the notices are
set forth in paragraph 7 of the Act (12
U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the office of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than
September 24, 2008.
A. Federal Reserve Bank of St. Louis
(Glenda Wilson, Community Affairs
Officer) P.O. Box 442, St. Louis,
Missouri 63166–2034:
1. Larry T. Wilson Descendents Trust
and The Kathryn W. Roberts
Descendants Trust to join the Wilson
Family Control Group, all of
Jacksonville, Arkansas, and thereby
acquire control of First Arkansas
Bancshares, Inc., and thereby indirectly
acquire control of First Arkansas Bank
and Trust, both of Jacksonville,
Arkansas.
Board of Governors of the Federal Reserve
System, September 4, 2008.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E8–20881 Filed 9–8–08; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL RESERVE SYSTEM
Sunshine Act Meeting
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 12:00 p.m., Monday,
September 15, 2008.
PLACE: Marriner S. Eccles Federal
Reserve Board Building, 20th and C
Streets, N.W., Washington, D.C. 20551.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
1. Personnel actions (appointments,
promotions, assignments,
reassignments, and salary actions)
involving individual Federal Reserve
System employees.
2. Any items carried forward from a
previously announced meeting.
FOR FURTHER INFORMATION CONTACT:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
SUPPLEMENTARY INFORMATION: You may
call 202–452–3206 beginning at
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
AGENCY HOLDING THE MEETING:
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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
Board of Governors of the Federal Reserve
System, September 5, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–20989 Filed 9–5–08; 4:15 pm]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2006–P–0081 (formerly
Docket No. 2006P–0178) and FDA–2005–P–
0369 (formerly Docket No. 2005P–0023)]
Determination That TEQUIN
(Gatifloxacin) Was 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 TEQUIN (gatifloxacin) Tablets,
Injection, and Oral Suspension, were
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
accept or approve abbreviated new drug
applications (ANDAs) for gatifloxacin
oral tablets, injection, or oral suspension
that refer to any previously approved
dosage forms and strengths of TEQUIN
(gatifloxacin).
FOR FURTHER INFORMATION CONTACT:
Elena Cohen, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6228, Silver Spring,
MD 20993–0002, 301–796–3602.
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 under an
ANDA procedure. ANDA applicants
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 under a new drug
application (NDA). ANDA applicants 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
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Food, Drug, and Cosmetic Act (the 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.’’ 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
(section 505(j)(7)(C) of the act; § 314.162
(21 CFR 314.162)).
FDA will not approve an ANDA if the
listed drug has been withdrawn from
sale for safety or effectiveness reasons
(section 505(j)(4)(I) of the act). 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. A drug that has been
withdrawn from the market for safety or
effectiveness reasons is not a listed drug
(21 CFR 314.3(b)). FDA may not approve
an ANDA that does not refer to a listed
drug. FDA currently has pending one or
more ANDAs that refer to TEQUIN
(gatifloxacin).
Bristol-Myers Squibb Co. (BMS) is the
holder of three NDAs1 for TEQUIN
tablets, injection, and oral suspension as
listed in the following table:
TABLE 1.—APPROVED TEQUIN PRODUCTS
NDA No.
Active Ingredients
Strength
Dosage Form/Route
21–061
Gatifloxacin
200 milligrams (mg)
Tablet; oral
21–061
Gatifloxacin
400 mg
Tablet; oral
21–062
Gatifloxacin
Equivalent to 10 mg/milliliter (mL) (200 mg)
Injectable; injection
21–062
Gatifloxacin
400 mg/40 mL (10 mg/mL)
Injectable; injection
21–062
Gatifloxacin in dextrose 5% in
plastic container
200 mg/100 mL (2 mg/mL)
Injectable; injection
21–062
Gatifloxacin in dextrose 5% in
plastic container
400 mg/200mL (2 mg/mL)
Injectable; injection
21–678
Gatifloxacin
200 mg/5 mL
Suspension; oral
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TEQUIN is an antibacterial drug
indicated for the treatment of infections
due to susceptible strains of designated
microorganisms in the following
conditions: Acute bacterial exacerbation
of chronic bronchitis; acute sinusitis;
1 On December 17, 1999, FDA approved NDAs
21–061 and 21–062 for community-acquired
pneumonia, acute bacterial exacerbation of chronic
bronchitis, acute bacterial sinusitis, uncomplicated
urinary tract infections, complicated urinary tract
infections, pyelonephritis, and uncomplicated
gonorrhea. The December 17, 1999, approval letter
also stated that indications for uncomplicated skin
and skin structure infections were approvable
pending the submission of certain postmarketing
data. For administrative purposes, the agency
assigned administrative NDAs 21–404 (TEQUIN
Tablets) and 21–405 (TEQUIN Injections) for the
treatment of uncomplicated skin and skin structure
infections. BMS provided a complete response, and
upon approval on October 17, 2002, NDAs 21–404
and 21–405 were retired by FDA. The approvals
and all other submissions for the treatment of
uncomplicated skin and skin structure infections
were incorporated in the original NDAs, 21–061
and 21–062. NDAs 21–404 and 21–405 are not
listed in the Orange Book, but can be found through
a search at Drugs@FDA.
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Agencies
[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Notices]
[Pages 52356-52357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20989]
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FEDERAL RESERVE SYSTEM
Sunshine Act Meeting
AGENCY HOLDING THE MEETING: Board of Governors of the Federal Reserve
System.
TIME AND DATE: 12:00 p.m., Monday, September 15, 2008.
PLACE: Marriner S. Eccles Federal Reserve Board Building, 20th and C
Streets, N.W., Washington, D.C. 20551.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
1. Personnel actions (appointments, promotions, assignments,
reassignments, and salary actions) involving individual Federal Reserve
System employees.
2. Any items carried forward from a previously announced meeting.
FOR FURTHER INFORMATION CONTACT: Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office of Board Members at 202-452-
2955.
SUPPLEMENTARY INFORMATION: You may call 202-452-3206 beginning at
approximately 5 p.m. two business days before the meeting for a
recorded announcement of bank and bank holding company applications
[[Page 52357]]
scheduled for the meeting; or you may contact the Board's Web site at
https://www.federalreserve.gov for an electronic announcement that not
only lists applications, but also indicates procedural and other
information about the meeting.
Board of Governors of the Federal Reserve System, September 5,
2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8-20989 Filed 9-5-08; 4:15 pm]
BILLING CODE 6210-01-S