Food and Drug Administration, 3374-3375 [05-1182]

Download as PDF 3374 Federal Register / Vol. 70, No. 14 / Monday, January 24, 2005 / Notices Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, comments on the AHRQ information collection proposal are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency’s estimate of the burden (including hours and costs) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and, (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: January 7, 2005. Carolyn M. Clancy, Director. [FR Doc. 05–1187 Filed 1–21–05; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Agency for Toxic Substances and Disease Registry [Program Announcement 05002] Public Health Conference Grant Program; Notice of Availability of Funds Amendment A notice announcing the availability of Fiscal Year 2005 funds to award a Grant Agreement to Support Public Health Conference Support Grant Agreement published in the Federal Register on November 2, 2004, Volume 69, Number 211, pages 63541–63546. The notice is amended as follows: On page 63543, second column, under III.3 Other, Special Requirements, second bullet, delete the bullet that reads, ‘‘Applicants who do not submit a LOI will not be eligible to submit an application for review or funding.’’ On page 63543, third column, under IV.2 Content and Form of Submission, Letter of Intent (LOI), first paragraph, delete the fifth sentence that reads, ‘‘If you do not submit a LOI, you will not be allowed to submit an application.’’ VerDate jul<14>2003 18:04 Jan 21, 2005 Jkt 205001 On page 63544, second column, under IV.3 Submission Dates and Times, delete the fourth paragraph that reads, ‘‘Applicants who do not submit an LOI will not be eligible to submit an application for review or funding.’’ Dated: January 14, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–1205 Filed 1–21–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Early Hearing Detection and Intervention (EHDI) Tracking, Surveillance, and Integration; Correction In the notice document announcing the ‘‘Early Hearing Detection and Intervention (EHDI) Tracking, Surveillance, and Integration,’’ Funding Opportunity Number: RFA 05028, appearing on page 357 in the Federal Register issue of Tuesday, January 4, 2005, the notice is amended as follows: On page 357, third column under DATES, and page 360, second column under Section IV.3. Submission Dates and Times: amend to reflect Letter of Intent Deadline (LOI) Date: February 10, 2005, and Application Deadline Date: March 14, 2005. On page 359, second column under Section III.3. Other: fourth bullet delete the semicolon and the word and [; and]; delete fifth bullet ‘‘Have previously been awarded a CDC Cooperative Agreement for EHDI Tracking, Surveillance, and Integration (Program Announcements 00076, 01048, or 03055).’’ Dated: January 14, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 05–1219 Filed 1–21–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00020 Fmt 4703 Sfmt 4703 This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee (CRDAC). General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 24, 2005, from 8 a.m. to 5 p.m. Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Cathy Groupe, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827–7001, e-mail: groupec@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512533. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss supplemental new drug applications (sNDAs) S–022, S–024, and S–025 to approved new drug application (NDA) 20–838, ATACAND (candesartan cilexetil) Tablets (4 milligrams (mg), 8 mg, 16 mg, and 32 mg), AstraZeneca LP, for the use in the treatment of patients with congestive heart failure, specifically in the following ways: (1) S–022, reducing the risk of cardiovascular mortality or heart failure hospitalization when added to an angiotensin-converting enzyme inhibitor-containing regimen in congestive heart failure patients with left ventricular systolic dysfunction; (2) S–024, reducing the risk of cardiovascular mortality or heart failure hospitalization in congestive heart failure patients with left ventricular systolic dysfunction, as a primary reninangiotensin-aldosterone system modulating treatment; and (3) S–025, reducing the frequency of hospitalizations for heart failure in congestive heart failure patients with preserved left ventricular systolic dysfunction. ATACAND is currently approved for use in the treatment of hypertension. The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https:// www.fda.gov/ohrms/dockets/ac/ acmenu.htm under the heading E:\FR\FM\24JAN1.SGM 24JAN1 Federal Register / Vol. 70, No. 14 / Monday, January 24, 2005 / Notices ‘‘Cardiovascular and Renal Drugs Advisory Committee.’’ (Click on the year 2005 and scroll down to CRDAC meetings.) Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 16, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 16, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Beverly O’Neil at 301–827–7001 at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 12, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–1182 Filed 1–21–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that the following committee will convene its forty-ninth meeting. Name: National Advisory Committee on Rural Health and Human Services. Dates and Times: March 20, 2005, 1:30 p.m.–4:30 p.m., March 21, 2005, 8:30 a.m.– 4:30 p.m., March 22, 2005, 8 a.m.–10:30 a.m. Place: Grand Hyatt, 1000 H Street, NW., Washington, DC 20001, Phone: 1–800–233– 1234. VerDate jul<14>2003 18:04 Jan 21, 2005 Jkt 205001 Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development and administration of health and human services in rural areas. Agenda: Sunday afternoon, March 20, at 1:30 p.m., the Chairperson, the Honorable David Beasley, will open the meeting and welcome the Committee. The first session will open with a discussion of the Committee business and a review of the 2005 report to the Secretary. This will be followed by an update from the Committee Staff represented by the following: Ms. Jennifer Riggle, Office of Rural Health Policy; Mr. Dennis Dudley, Agency on Aging; and Ms. Ann Barbagallo, Administration on Children and Families. The final session of the day will consist of an in-depth review and adoption of the 2005 report to the Secretary. The Sunday meeting will close at 4:30 p.m. Monday morning, March 21, at 8:30 a.m. the meeting will begin with the 2006 Report Planning, led by the Honorable David Beasley and Mr. Tom Morris, the Executive Secretary of the Committee. The Committee will hear presentations from Staff on each potential 2006 topic. The Committee will break for a joint lunch with the National Rural Health Association Policy Institute (lunch will be provided for the Committee only). After lunch the Committee will hear a panel discussion on rural health and human services emerging issues. The Monday session will conclude with a continued discussion of the 2006 Workplan. The Monday meeting will close at 4:30 p.m. The final session will be convened Tuesday morning, March 22, at 8 a.m. The Committee will review the discussion of the 2006 Workplan. The meeting will conclude with a discussion of the June and September meetings. The meeting will be adjourned at 10:30 a.m. 3375 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meeting: FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the Committee should contact Tom Morris, M.P.A., Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, Room 9A–55, 5600 Fishers Lane, Rockville, MD 20857, telephone (301) 443–0835, Fax (301) 443–2803. Persons interested in attending any portion of the meeting should contact Deanna Durrett, Office of Rural Health Policy (ORHP), by telephone (301) 443– 0835, or e-mail ddurrett@hrsa.gov. The Committee meeting agenda will be posted on ORHP’s Web site at https:// www.ruralhealth.hrsa.gov. Name: Advisory Committee on Training in Primary Care Medicine and Dentistry. Dates and Times: February 10, 2005, 8:30 a.m.–4:30 p.m., February 11, 2005, 8 a.m.–2 p.m. Place: DoubleTree Hotel Rockville, 1750 Rockville Pike, Rockville, Maryland 20852 Status: The meeting will be open to the public. Purpose: The Advisory Committee provides advice and recommendations on a broad range of issues dealing with programs and activities authorized under section 747 of the Public Health Service Act as amended by The Health Professions Education Partnership Act of 1998, Public Law 105– 392. At this meeting the Advisory Committee will continue to work on its fifth report which will be submitted to Congress and to the Secretary of the Department of Health and Human Services in November 2005 and which focuses on measuring outcomes of Title VII, section 747 grant programs. Agenda: The meeting on Thursday, February 10, will begin with opening comments from the Chair of the Advisory Committee. A plenary session will follow in which Advisory Committee members will discuss various sections of the fifth report. The Advisory Committee will divide into workgroups to further develop the fifth report. An opportunity will be provided for public comment. On Friday, February 11, the Advisory Committee will meet in plenary session to continue its work on the fifth report. An opportunity will be provided for public comment. For Further Information Contact: Anyone interested in obtaining a roster of members or other relevant information should write or contact Jerilyn K. Glass, M.D., Ph.D., Division of Medicine and Dentistry, Bureau of Health Professions, Health Resources and Services Administration, Room 9A–27, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–6326. The Web address for information on the Advisory Committee is https://bhpr.hrsa.gov/ medicine-dentistry/actpcmd. Dated: January 13, 2005. Steven A. Pelovitz, Associate Administrator for Administration and Financial Management. [FR Doc. 05–1183 Filed 1–21–05; 8:45 am] Dated: January 13, 2005. Steven A. Pelovitz, Associate Administrator for Administration and Financial Management. [FR Doc. 05–1184 Filed 1–21–05; 8:45 am] BILLING CODE 4165–15–P BILLING CODE 4165–15–P PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\24JAN1.SGM 24JAN1

Agencies

[Federal Register Volume 70, Number 14 (Monday, January 24, 2005)]
[Notices]
[Pages 3374-3375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration Cardiovascular and Renal Drugs 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory 
Committee (CRDAC).
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 24, 2005, from 
8 a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers 
Lane, Rockville, MD.
    Contact Person: Cathy Groupe, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 
20857, 301-827-7001, e-mail: groupec@cder.fda.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512533. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss supplemental new drug 
applications (sNDAs) S-022, S-024, and S-025 to approved new drug 
application (NDA) 20-838, ATACAND (candesartan cilexetil) Tablets (4 
milligrams (mg), 8 mg, 16 mg, and 32 mg), AstraZeneca LP, for the use 
in the treatment of patients with congestive heart failure, 
specifically in the following ways: (1) S-022, reducing the risk of 
cardiovascular mortality or heart failure hospitalization when added to 
an angiotensin-converting enzyme inhibitor-containing regimen in 
congestive heart failure patients with left ventricular systolic 
dysfunction; (2) S-024, reducing the risk of cardiovascular mortality 
or heart failure hospitalization in congestive heart failure patients 
with left ventricular systolic dysfunction, as a primary renin-
angiotensin-aldosterone system modulating treatment; and (3) S-025, 
reducing the frequency of hospitalizations for heart failure in 
congestive heart failure patients with preserved left ventricular 
systolic dysfunction. ATACAND is currently approved for use in the 
treatment of hypertension. The background material will become 
available no later than the day before the meeting and will be posted 
on FDA's Web site at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm 
under the heading

[[Page 3375]]

``Cardiovascular and Renal Drugs Advisory Committee.'' (Click on the 
year 2005 and scroll down to CRDAC meetings.)
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by February 16, 
2005. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before February 16, 2005, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Beverly O'Neil at 
301-827-7001 at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 12, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1182 Filed 1-21-05; 8:45 am]
BILLING CODE 4160-01-S

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