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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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Federal Register / Vol. 70, No. 14 / Monday, January 24, 2005 / Notices 3375

‘‘Cardiovascular and Renal Drugs Status: The meeting will be open to the DEPARTMENT OF HEALTH AND
Advisory Committee.’’ (Click on the public. HUMAN SERVICES
year 2005 and scroll down to CRDAC Purpose: The National Advisory
Committee on Rural Health and Human Health Resources and Services
meetings.) Services provides advice and
Procedure: Interested persons may recommendations to the Secretary with Administration
present data, information, or views, respect to the delivery, research,
orally or in writing, on issues pending development and administration of health Advisory Committee on Training in
before the committee. Written and human services in rural areas. Primary Care Medicine and Dentistry;
submissions may be made to the contact Agenda: Sunday afternoon, March 20, at Notice of Meeting
person by February 16, 2005. Oral 1:30 p.m., the Chairperson, the Honorable
presentations from the public will be David Beasley, will open the meeting and
welcome the Committee. The first session In accordance with section 10(a)(2) of
scheduled between approximately 1 the Federal Advisory Committee Act
will open with a discussion of the Committee
p.m. and 2 p.m. Time allotted for each business and a review of the 2005 report to (Public Law 92–463), notice is hereby
presentation may be limited. Those the Secretary. This will be followed by an given of the following meeting:
desiring to make formal oral update from the Committee Staff represented
presentations should notify the contact Name: Advisory Committee on Training in
by the following: Ms. Jennifer Riggle, Office
Primary Care Medicine and Dentistry.
person before February 16, 2005, and of Rural Health Policy; Mr. Dennis Dudley,
Dates and Times: February 10, 2005, 8:30
submit a brief statement of the general Agency on Aging; and Ms. Ann Barbagallo,
Administration on Children and Families. a.m.–4:30 p.m., February 11, 2005, 8 a.m.–2
nature of the evidence or arguments p.m.
they wish to present, the names and The final session of the day will consist of
an in-depth review and adoption of the 2005 Place: DoubleTree Hotel Rockville, 1750
addresses of proposed participants, and Rockville Pike, Rockville, Maryland 20852
report to the Secretary. The Sunday meeting
an indication of the approximate time will close at 4:30 p.m. Status: The meeting will be open to the
requested to make their presentation. Monday morning, March 21, at 8:30 a.m. public.
Persons attending FDA’s advisory the meeting will begin with the 2006 Report Purpose: The Advisory Committee
committee meetings are advised that the Planning, led by the Honorable David provides advice and recommendations on a
agency is not responsible for providing Beasley and Mr. Tom Morris, the Executive broad range of issues dealing with programs
access to electrical outlets. Secretary of the Committee. The Committee and activities authorized under section 747
FDA welcomes the attendance of the will hear presentations from Staff on each of the Public Health Service Act as amended
public at its advisory committee potential 2006 topic. The Committee will by The Health Professions Education
meetings and will make every effort to break for a joint lunch with the National Partnership Act of 1998, Public Law 105–
accommodate persons with physical Rural Health Association Policy Institute 392. At this meeting the Advisory Committee
(lunch will be provided for the Committee will continue to work on its fifth report
disabilities or special needs. If you only). After lunch the Committee will hear a
require special accommodations due to which will be submitted to Congress and to
panel discussion on rural health and human the Secretary of the Department of Health
a disability, please contact Beverly services emerging issues. The Monday and Human Services in November 2005 and
O’Neil at 301–827–7001 at least 7 days session will conclude with a continued which focuses on measuring outcomes of
in advance of the meeting. discussion of the 2006 Workplan. The Title VII, section 747 grant programs.
Notice of this meeting is given under Monday meeting will close at 4:30 p.m. Agenda: The meeting on Thursday,
the Federal Advisory Committee Act (5 The final session will be convened February 10, will begin with opening
U.S.C. app. 2). Tuesday morning, March 22, at 8 a.m. The comments from the Chair of the Advisory
Committee will review the discussion of the
Dated: January 12, 2005. Committee. A plenary session will follow in
2006 Workplan. The meeting will conclude
Sheila Dearybury Walcoff, which Advisory Committee members will
with a discussion of the June and September
discuss various sections of the fifth report.
Associate Commissioner for External meetings. The meeting will be adjourned at
10:30 a.m. The Advisory Committee will divide into
Relations.
workgroups to further develop the fifth
[FR Doc. 05–1182 Filed 1–21–05; 8:45 am] FOR FURTHER INFORMATION CONTACT: report. An opportunity will be provided for
BILLING CODE 4160–01–S Anyone requiring information regarding public comment.
the Committee should contact Tom On Friday, February 11, the Advisory
Morris, M.P.A., Executive Secretary, Committee will meet in plenary session to
DEPARTMENT OF HEALTH AND National Advisory Committee on Rural continue its work on the fifth report. An
HUMAN SERVICES Health and Human Services, Health opportunity will be provided for public
Resources and Services Administration, comment.
Health Resources and Services Parklawn Building, Room 9A–55, 5600 For Further Information Contact:
Administration Fishers Lane, Rockville, MD 20857, Anyone interested in obtaining a roster of
telephone (301) 443–0835, Fax (301) members or other relevant information
National Advisory Committee on Rural should write or contact Jerilyn K. Glass,
443–2803. M.D., Ph.D., Division of Medicine and
Health and Human Services; Notice of Persons interested in attending any
Meeting Dentistry, Bureau of Health Professions,
portion of the meeting should contact Health Resources and Services
In accordance with section 10(a)(2) of Deanna Durrett, Office of Rural Health Administration, Room 9A–27, Parklawn
the Federal Advisory Committee Act Policy (ORHP), by telephone (301) 443– Building, 5600 Fishers Lane, Rockville,
(Pub. L. 92–463), notice is hereby given 0835, or e-mail ddurrett@hrsa.gov. The Maryland 20857, Telephone (301) 443–6326.
that the following committee will Committee meeting agenda will be The Web address for information on the
convene its forty-ninth meeting. posted on ORHP’s Web site at http:// Advisory Committee is http://bhpr.hrsa.gov/
www.ruralhealth.hrsa.gov. medicine-dentistry/actpcmd.
Name: National Advisory Committee on
Rural Health and Human Services. Dated: January 13, 2005. Dated: January 13, 2005.
Dates and Times: March 20, 2005, 1:30 Steven A. Pelovitz, Steven A. Pelovitz,
p.m.–4:30 p.m., March 21, 2005, 8:30 a.m.– Associate Administrator for Administration
Associate Administrator for Administration
4:30 p.m., March 22, 2005, 8 a.m.–10:30 a.m.
and Financial Management. and Financial Management.
Place: Grand Hyatt, 1000 H Street, NW.,
Washington, DC 20001, Phone: 1–800–233– [FR Doc. 05–1183 Filed 1–21–05; 8:45 am] [FR Doc. 05–1184 Filed 1–21–05; 8:45 am]
1234. BILLING CODE 4165–15–P BILLING CODE 4165–15–P

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