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9358 Federal Register / Vol. 71, No.

36 / Thursday, February 23, 2006 / Notices

21), Food and Drug Administration, an indication of the approximate time SUPPLEMENTARY INFORMATION: In the
5600 Fishers Lane (for express delivery, requested to make their presentation. Federal Register of January 27, 2006,
5630 Fishers Lane, rm. 1093) Rockville, Persons attending FDA’s advisory FDA announced that a meeting of the
MD 20857, 301–827–7001, e-mail: committee meetings are advised that the Peripheral and Central Nervous System
Cathy.Groupe@fda.hhs.gov, or FDA agency is not responsible for providing Drugs Advisory Committee would be
Advisory Committee Information Line, access to electrical outlets. held on March 7, 2006, from 8 a.m. to
1–800–741–8138 (301–443–0572 in the FDA welcomes the attendance of the 5 p.m., and the open public hearing
Washington, DC area), code public at its advisory committee portion scheduled between
3014512533. Please call the Information meetings and will make every effort to approximately 1 p.m. and 2 p.m. On
Line for up-to-date information on this accommodate persons with physical page 4593, in the third column, the Date
meeting. disabilities or special needs. If you and Time portion of the document is
Agenda: On April 25, 2006, the require special accommodations due to amended to read as follows:
committee will meet between 8 a.m. to a disability, please contact John Date and Time: The meeting will be
5 p.m., to discuss new drug application Lauttman at least 7 days in advance of held on March 7 and 8, 2006, from 8
(NDA) 21–359 CELLEGESIC the meeting at 301–827–7001. a.m. to 5 p.m.
(nitroglycerin [NTG] ointment), 0.4% Notice of this meeting is given under On page 4594, in the first column, in
intra-anal, Cellegy Pharmaceuticals, the Federal Advisory Committee Act (5 the Procedure portion of the document,
Inc., for the proposed indication of relief U.S.C. app. 2). the third sentence is amended to read as
of pain associated with anal fissures. On follows:
April 26, 2006, the committee will meet Dated: February 15, 2006. Procedure: Oral presentations from
between 8 a.m. to 12 noon, to discuss Jason Brodsky, the public will be scheduled between
the agency’s draft recommendations for Acting Associate Commissioner for External approximately 1 p.m. and 5 p.m. on
relabeling of antihypertensive drugs for Relations. March 7, 2006.
outcome claims, as a followup to the [FR Doc. E6–2542 Filed 2–22–06; 8:45 am] This notice is issued under the
committee’s meeting on June 15, 2005, BILLING CODE 4160–01–S Federal Advisory Committee Act (5
where the committee discussed class U.S.C. app. 2) and 21 CFR part 14,
labeling of antihypertensive drugs based relating to the advisory committees.
on the proximity of their data to DEPARTMENT OF HEALTH AND Dated: February 15, 2006.
outcome trials. Following this, from HUMAN SERVICES
Jason Brodsky,
approximately 1 p.m. to 5 p.m., the
Food and Drug Administration Acting Associate Commissioner for External
committee will discuss the ‘‘Placebo in
Relations.
Hypertension Adverse Reaction Meta-
Analysis’’ Study, a meta-analysis of Peripheral and Central Nervous [FR Doc. E6–2541 Filed 2–22–06; 8:45 am]
more than 80,000 patients in placebo- System Drugs Advisory Committee; BILLING CODE 4160–01–S

controlled trials of antihypertensive Amendment of Notice


medications, which evaluated the risk of AGENCY: Food and Drug Administration,
irreversible harm in conducting DEPARTMENT OF HEALTH AND
HHS. HUMAN SERVICES
placebo-controlled trials in patients
with hypertension. The background ACTION: Notice.
National Institutes of Health
material will become available no later The Food and Drug Administration
than the day before the meeting and will (FDA) is announcing an amendment to National Institute of Environmental
be posted on FDA’s Web site at http:// the notice of meeting of the Peripheral Health Sciences; Proposed Collection;
www.fda.gov/orhms/dockets/ac/ and Central Nervous System Drugs Comment Request; The Sister Study: A
acmenu.htm under the heading Advisory Committee. This meeting was Prospective Study of the Genetic and
‘‘Cardiovascular and Renal Drugs announced in the Federal Register of Environmental Risk Factors for Breast
Advisory Committee.’’ (Click on the Cancer
January 27, 2006 (71 FR 4593). The
year 2006 and scroll down to the above
amendment is being made to reflect a SUMMARY: In compliance with the
named committee).
Procedure: Interested persons may change in Date and Time and Procedure requirement of section 3506(c)(2)(A) of
present data, information, or views, portions of the document. An additional the Paperwork Reduction Act of 1995,
orally or in writing, on issues pending day is being added to this meeting and for opportunity for public comment on
before the committee. Written the length of time allotted for the open proposed data collection projects, the
submissions may be made to the contact public hearing portion is being National Institute of Environmental
person by April 14, 2006. On April 25, extended. There are no other changes. Health Sciences (NIEHS), the National
2006, oral presentations from the public FOR FURTHER INFORMATION CONTACT: Institutes of Health (NIH) will publish
will be scheduled between Sohail Mosaddegh, Center for Drug periodic summaries of proposed
approximately 8:15 a.m. to 8:45 a.m. On Evaluation and Research (HFD–21), projects to be submitted to the Office of
April 26, 2006, oral presentations from Food and Drug Administration, 5600 Management and Budget (OMB) for
the public will be scheduled between Fishers Lane (for express delivery, 5630 review and approval.
approximately 8:15 a.m. to 8:45 a.m. Fishers Lane, rm. 1093), Rockville, MD Proposed Collection: Title: The Sister
and 1 p.m. to 1:30 p.m. Time allotted for 20857, 301–827–7001, FAX: 301–827– Study: A Prospective Study of the
each presentation may be limited. Those 6776, e-mail: Genetic and Environmental Risk Factors
desiring to make formal oral sohail.mosaddegh@fda.hhs.gov, or the for Breast Cancer. Type of Information
presentations should notify the contact FDA Advisory Committee Information Collection Request: Revision of OMB
rwilkins on PROD1PC63 with NOTICES

person before April 14, 2006, and Line, 1–800–741–8138 (301–443–0572 No. 0925–0522 and expiration date 31
submit a brief statement of the general in the Washington DC area), code July 2006. Need and Use of Information
nature of the evidence or arguments 3014512543. Please call the Information Collection: The purpose of the Sister
they wish to present, the names and Line for up-to-date information on this Study is to study genetic and
addresses of proposed participants and meeting. environmental risk factors for the

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