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3374 Federal Register / Vol. 70, No.

14 / Monday, January 24, 2005 / Notices

Request for Comments On page 63544, second column, under This notice announces a forthcoming
In accordance with the above-cited IV.3 Submission Dates and Times, meeting of a public advisory committee
Paperwork Reduction Act legislation, delete the fourth paragraph that reads, of the Food and Drug Administration
comments on the AHRQ information ‘‘Applicants who do not submit an LOI (FDA). The meeting will be open to the
collection proposal are requested with will not be eligible to submit an public.
regard to any of the following: (a) application for review or funding.’’ Name of Committee: Cardiovascular
Dated: January 14, 2005. and Renal Drugs Advisory Committee
Whether the proposed collection of
(CRDAC).
information is necessary for the proper William P. Nichols,
General Function of the Committee:
performance of functions of the Agency, Director, Procurement and Grants Office, To provide advice and
including whether the information will Centers for Disease Control and Prevention.
recommendations to the agency on
have practical utility; (b) the accuracy of [FR Doc. 05–1205 Filed 1–21–05; 8:45 am] FDA’s regulatory issues.
the Agency’s estimate of the burden BILLING CODE 4163–18–P Date and Time: The meeting will be
(including hours and costs) of the held on February 24, 2005, from 8 a.m.
proposed collection of information; (c) to 5 p.m.
ways to enhance the quality, utility, and DEPARTMENT OF HEALTH AND Location: Food and Drug
clarity of the information to be HUMAN SERVICES Administration, Center for Drug
collected; and, (d) ways to minimize the Evaluation and Research Advisory
burden of the collection of information Centers for Disease Control and
Committee Conference Room, rm. 1066,
on respondents, including the use of Prevention
5630 Fishers Lane, Rockville, MD.
automated collection techniques or Contact Person: Cathy Groupe, Center
Early Hearing Detection and
other forms of information technology. for Drug Evaluation and Research (HFD–
Comments submitted in response to Intervention (EHDI) Tracking,
Surveillance, and Integration; 21), Food and Drug Administration,
this notice will be summarized and 5600 Fishers Lane, (for express delivery,
Correction
included in the request for OMB 5630 Fishers Lane, rm. 1093) Rockville,
approval of the proposed information In the notice document announcing MD 20857, 301–827–7001, e-mail:
collection. All comments will become a the ‘‘Early Hearing Detection and groupec@cder.fda.gov, or FDA Advisory
matter of public record. Intervention (EHDI) Tracking, Committee Information Line, 1–800–
Dated: January 7, 2005. Surveillance, and Integration,’’ Funding 741–8138 (301–443–0572 in the
Carolyn M. Clancy, Opportunity Number: RFA 05028, Washington, DC area), code
appearing on page 357 in the Federal 3014512533. Please call the Information
Director.
Register issue of Tuesday, January 4, Line for up-to-date information on this
[FR Doc. 05–1187 Filed 1–21–05; 8:45 am] 2005, the notice is amended as follows: meeting.
BILLING CODE 4160–90–M On page 357, third column under Agenda: The committee will discuss
DATES, and page 360, second column supplemental new drug applications
under Section IV.3. Submission Dates (sNDAs) S–022, S–024, and S–025 to
DEPARTMENT OF HEALTH AND and Times: amend to reflect Letter of approved new drug application (NDA)
HUMAN SERVICES Intent Deadline (LOI) Date: February 10, 20–838, ATACAND (candesartan
Centers for Disease Control and 2005, and Application Deadline Date: cilexetil) Tablets (4 milligrams (mg), 8
Prevention March 14, 2005. mg, 16 mg, and 32 mg), AstraZeneca LP,
On page 359, second column under for the use in the treatment of patients
Section III.3. Other: fourth bullet delete with congestive heart failure,
Agency for Toxic Substances and
the semicolon and the word and [; and]; specifically in the following ways: (1)
Disease Registry
delete fifth bullet ‘‘Have previously S–022, reducing the risk of
[Program Announcement 05002] been awarded a CDC Cooperative cardiovascular mortality or heart failure
Agreement for EHDI Tracking, hospitalization when added to an
Public Health Conference Grant Surveillance, and Integration (Program angiotensin-converting enzyme
Program; Notice of Availability of Announcements 00076, 01048, or inhibitor-containing regimen in
Funds Amendment 03055).’’ congestive heart failure patients with
A notice announcing the availability Dated: January 14, 2005. left ventricular systolic dysfunction; (2)
of Fiscal Year 2005 funds to award a William P. Nichols, S–024, reducing the risk of
Grant Agreement to Support Public Director, Procurement and Grants Office, cardiovascular mortality or heart failure
Health Conference Support Grant Centers for Disease Control and Prevention hospitalization in congestive heart
Agreement published in the Federal (CDC). failure patients with left ventricular
Register on November 2, 2004, Volume [FR Doc. 05–1219 Filed 1–21–05; 8:45 am] systolic dysfunction, as a primary renin-
69, Number 211, pages 63541–63546. BILLING CODE 4163–18–P angiotensin-aldosterone system
The notice is amended as follows: modulating treatment; and (3) S–025,
On page 63543, second column, under reducing the frequency of
III.3 Other, Special Requirements, DEPARTMENT OF HEALTH AND hospitalizations for heart failure in
second bullet, delete the bullet that HUMAN SERVICES congestive heart failure patients with
reads, ‘‘Applicants who do not submit a preserved left ventricular systolic
LOI will not be eligible to submit an Food and Drug Administration dysfunction. ATACAND is currently
application for review or funding.’’ approved for use in the treatment of
On page 63543, third column, under Cardiovascular and Renal Drugs hypertension. The background material
IV.2 Content and Form of Submission, Advisory Committee; Notice of Meeting will become available no later than the
Letter of Intent (LOI), first paragraph, AGENCY: Food and Drug Administration, day before the meeting and will be
delete the fifth sentence that reads, ‘‘If HHS. posted on FDA’s Web site at http://
you do not submit a LOI, you will not www.fda.gov/ohrms/dockets/ac/
ACTION: Notice.
be allowed to submit an application.’’ acmenu.htm under the heading

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