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Federal Register / Vol. 71, No.

64 / Tuesday, April 4, 2006 / Notices 16779

Dated: March 16, 2006. FEDERAL TRADE COMMISSION The FTC Act and other laws the
John C. Dugan, Commission administers permit the
Comptroller of the Currency. Agency Information Collection collection of public comments to
By order of the Board of Governors of the Activities; Comment Request consider and use in this proceeding as
Federal Reserve System, March 28, 2006. appropriate. All timely and responsive
AGENCY: Federal Trade Commission public comments will be considered by
Jennifer J. Johnson, (‘‘FTC’’ or ‘‘Commission’’).
Secretary of the Board. the Commission and will be available to
ACTION: Notice. the public on the FTC Web site, to the
Dated at Washington, DC, this 29th day of
March, 2006. extent practicable, at
SUMMARY: The FTC is considering
As a matter of discretion, the FTC makes
Federal Deposit Insurance Corporation. conducting a study to analyze the use every effort to remove home contact
Robert E. Feldman, and likely short- and long-run information for individuals from the
Executive Secretary. competitive effects of authorized generic public comments it receives before
Dated: February 24, 2006. drugs in the prescription drug placing those comments on the FTC
By the Office of Thrift Supervision. marketplace. Before investigating these Web site. More information, including
John M. Reich, issues, the FTC is soliciting public routine uses permitted by the Privacy
Director. comments on its proposed information Act, may be found in the FTC’s privacy
[FR Doc. 06–3179 Filed 4–3–06; 8:45 am]
requests to firms in the prescription policy at
drug industry. These comments will be privacy.htm.
BILLING CODE 4810–33–P; 6210–01–P; 6714–01–P;
6720–01–P considered before the FTC submits a
request for Office of Management and FOR FURTHER INFORMATION CONTACT:
Budget (‘‘OMB’’) review under the Requests for additional information
Paperwork Reduction Act (‘‘PRA’’), 44 should be addressed to Michael S.
FEDERAL RESERVE SYSTEM U.S.C. 3501–3520. Wroblewski, Assistant General Counsel,
Policy Studies, 600 Pennsylvania
DATES: Comments must be received on
Sunshine Act Meeting Avenue, NW., Washington, DC 20580;
or before June 5, 2006.
telephone (202) 326–2155.
AGENCY HOLDING THE MEETING: Board of ADDRESSES: Interested parties are
Governors of the Federal Reserve invited to submit written comments.
United States, the Food and Drug
System. Comments should refer to ‘‘Authorized
Administration (‘‘FDA’’) must approve
TIME AND DATE: 11:30 a.m., Monday,
Generic Drug Study: FTC Project No.
the marketing of any pharmaceutical
April 10, 2006 P062105’’ to facilitate the organization
drug, whether brand-name or generic.
of comments. A comment filed in paper
PLACE: Marriner S. Eccles Federal The Hatch-Waxman Act establishes the
form should include this reference both
Reserve Board Building, 20th and C regulatory framework under which the
in the text and on the envelope and
Streets, N.W., Washington, D.C. 20551. FDA may approve a generic drug to be
should be mailed or delivered, with two
STATUS: Closed.
marketed. Typically, a brand-name drug
complete copies, to the following
obtains FDA approval through a New
MATTERS TO BE CONSIDERED: address: Federal Trade Commission/
Drug Application (‘‘NDA’’), and a
1. Personnel actions (appointments, Office of the Secretary, Room H–135
generic drug manufacturer obtains FDA
promotions, assignments, (Annex J), 600 Pennsylvania Avenue,
approval through an Abbreviated New
reassignments, and salary actions) NW., Washington, DC 20580. Because
Drug Application (‘‘ANDA’’) in which it
involving individual Federal Reserve paper mail in the Washington area and
may be allowed to rely on the clinical
System employees. at the Commission is subject to delay,
data first submitted by the brand-name
2. Any items carried forward from a please consider submitting your
drug manufacturer.
previously announced meeting. comments in electronic form, as To encourage generic entry as soon as
prescribed below. However, if the is warranted, the Hatch-Waxman Act
comment contains any material for allows generic drug manufacturers, in
Michelle Smith, Director, or Dave
which confidential treatment is certain circumstances, to market a
Skidmore, Assistant to the Board, Office
requested, it must be filed in paper generic drug prior to the expiration of
of Board Members at 202–452–2955.
form, and the first page of the document claimed patent protection for the
SUPPLEMENTARY INFORMATION: You may must be clearly labeled ‘‘Confidential.’’ 1
call 202–452–3206 beginning at corresponding brand-name drug. To be
The FTC is requesting that any comment permitted to do so, a generic drug
approximately 5 p.m. two business days filed in paper form be sent by courier or
before the meeting for a recorded manufacturer must first submit a
overnight service, if possible. ‘‘paragraph IV’’ ANDA in which it
announcement of bank and bank Alternatively, comments may be filed in
holding company applications certifies that (a) its generic drug will not
electronic form (in ASCII format, infringe patents listed in the FDA’s
scheduled for the meeting; or you may WordPerfect, or Microsoft Word) as part
contact the Board’s Web site at http:// ‘‘Orange Book’’ (‘‘Orange Book patents’’)
of or as an attachment to email messages as claiming the relevant brand-name for an electronic directed to the following e-mail box:
announcement that not only lists drug product, and/or (b) the relevant Orange Book patents are invalid. If the
applications, but also indicates
procedural and other information about paragraph IV ANDA leads to litigation,
1 Commission Rule 4.2(d), 16 CFR 4.2(d). The
the meeting. then 30 months after the litigation was
comment must be accompanied by an explicit
request for confidential treatment, including the filed (or after final decision in the
Board of Governors of the Federal Reserve litigation, if earlier), the FDA may
sroberts on PROD1PC70 with NOTICES

factual and legal basis for the request, and must

System, March 31, 2006. identify the specific portions of the comment to be authorize the marketing of the generic
Robert deV. Frierson, withheld from the public record. The request will drug under the ANDA application.
Deputy Secretary of the Board. be granted or denied by the Commission’s General
Counsel, consistent with applicable law and the
At that point, the first-filed paragraph
[FR Doc. 06–3276 Filed 3–31–06; 2:03 pm] public interest. See Commission Rule 4.9(c), 16 CFR IV ANDA applicant becomes entitled to
BILLING CODE 6210–01–S 4.9(c). a 180-day marketing exclusivity period,

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