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8 / Wednesday, January 12, 2005 / Notices

2. Any items carried forward from a
previously announced meeting.
FOR FURTHER INFORMATION CONTACT:
Michelle A. Smith, Director, Office of
Board Members; 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
scheduled for the meeting; or you may
contact the Board’s Web site at http://
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, January 10, 2005.
Robert dev. Frierson,
Deputy Secretary of the Board.
[FR Doc. 05–703 Filed 1–10–05; 11:23 am]
BILLING CODE 6210–01–S
FEDERAL RETIREMENT THRIFT
INVESTMENT BOARD
Sunshine Act Notice
TIME AND DATE: 9 a.m. (EST), January 19,
2005.
PLACE:4th Floor Conference Room,
1250 H Street, NW., Washington, DC.
STATUS: Parts will be open to the public
and parts closed to the public.
MATTERS TO BE CONSIDERED:
Parts Open to the Public
1. Approval of the minutes of the
December 20, 2004, Board member
meeting.
2. Thrift Savings Plan activity report
by the Executive Director.
3. Investment policy quarterly review.
Parts Closed to the Public
4. Procurement.
5. Personnel matters.
CONTACT PERSON FOR MORE INFORMATION:
Thomas J. Trabucco, Director, Office of
External Affairs, (202) 942–1640.
Dated: January 10, 2005.
Elizabeth S. Woodruff,
Secretary to the Board, Federal Retirement
Thrift Investment Board.
[FR Doc. 05–721 Filed 1–10–05; 12:56 pm]
BILLING CODE 6760–01–P
FEDERAL TRADE COMMISSION
Granting of Request for Early
Termination of the Waiting Period
Under the Premerger Notification
Rules
Section 7A of the Clayton Act, 15
U.S.C. 18a, as added by Title II of the
Hart-Scott-Rodino Antitrust
Improvements Act of 1976, requires
persons contemplating certain mergers
or acquisitions to give the Federal Trade
Commission and the Assistant Attorney
General advance notice and to wait
designated periods before
consummation of such plans. Section
7A(b)(2) of the Act permits the agencies,
in individual cases, to terminate this
waiting period prior to its expiration
and requires that notice of this action be
published in the Federal Register.
The following transactions were
granted early termination of the waiting
period provided by law and the
premerger notification rules. The grants
were made by the Federal Trade
Commission and the Assistant Attorney
General for the Antitrust Division of the
Department of Justice. Neither agency
intends to take any action with respect
to these proposed acquisitions during
the applicable waiting period.
BILLING CODE 6750–01–M

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FOR FURTHER INFORMATION CONTACT:
Sandra M. Peay, Contact Representative
or Renee Hallman, Case Management
Assistant, Federal Trade Commission,
Premerger Notification Office, Bureau of
Competition, Room H–303, Washington,
DC 20580, (202) 326–3100.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–594 Filed 1–11–04; 8:45 am]
BILLING CODE 6750–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0003]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Product Labeling; Medication Guide
Requirements
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
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regulations requiring the distribution of
patient labeling, called Medication
Guides, for certain products that pose a
serious and significant public health
concern requiring distribution of FDA-
approved patient medication
information.
DATES: Submit written or electronic
comments on the collection of
information by March 14, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: http://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: Under the
PRA, (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
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including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prescription Drug Product Labeling;
Medication Guide Requirements (OMB
Control Number 0910–0393)—Extension
FDA regulations require the
distribution of Medication Guides for
certain prescription human drug and
biological products used primarily on
an outpatient basis that pose a serious
and significant public health concern
requiring distribution of FDA-approved
patient medication information. These
Medication Guides inform patients
about the most important information
they should know about these products
in order to use them safely and
effectively. Included is information such
as the drug’s approved uses,
contraindications, adverse drug
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