Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting, 9357-9358 [E6-2542]

Download as PDF Federal Register / Vol. 71, No. 36 / Thursday, February 23, 2006 / Notices allocations and justifications are required for Federal funds. * Applications will be evaluated based on the extent to which they discuss and justify the costs of the proposed project as being reasonable and programmatically justified in view of the activities to be conducted and the anticipated results and benefits. (3 points). * Applications will be evaluated based on the extent to which they describe the fiscal controls and accounting procedures that will be used to ensure prudent use, proper disbursement, and accurate accounting of funds received under this program announcement. (2 points). Note: Applicants have the option of omitting the Social Security Numbers and specific salary rates of the proposed project personnel from the two copies submitted with the original applications to ACF. For purposes of the outside review process, applicants may elect to summarize salary information on the copies of their application. All necessary salary information must, however, appear on the signed original application for ACF. rwilkins on PROD1PC63 with NOTICES 2. Review and Selection Process No grant award will be made under this announcement on the basis of an incomplete application. Each application submitted under this program announcement will undergo a pre-review to determine that (1) the application was received by the closing date (See Section IV.3) and (2) that the amount requested does not exceed the stated ceiling (See Section II). It is necessary that applicants state specifically for which funding announcement they are applying. Applications will be evaluated and rated by an independent review panel on the basis of specific evaluation criteria. The results of these reviews will assist the ADD Commissioner and program staff in considering competing applications. Reviewers’ scores will weigh heavily in funding decisions but will not be the only factors considered. Applications generally will be considered in order of the average scores assigned by reviewers. The evaluation criteria were designed to assess the quality of a proposed project and to determine the likelihood of its success. The evaluation criteria are closely related and are considered as a whole in judging the overall quality of an application. Points are awarded only to applications that are responsive to the evaluation criteria within the context of this program announcement. NonFederal reviewers will be used for the review process. VerDate Aug<31>2005 16:15 Feb 22, 2006 Jkt 205001 Please reference Section IV.2 for information on non-Federal reviewers in the review process. Approved but Unfunded Applications Applications that are approved but unfunded may be held over for funding in the next funding cycle, pending the availability of funds, for a period not to exceed one year. VI. Award Administration Information 1. Award Notices The successful applicants will be notified through the issuance of a Financial Assistance Award document which sets forth the amount of funds granted, the terms and conditions of the grant, the effective date of the grant, the budget period for which initial support will be given, the non-Federal share to be provided (if applicable), and the total project period for which support is contemplated. The Financial Assistance Award will be signed by the Grants Officer and transmitted via postal mail. Organizations whose applications will not be funded will be notified in writing. 2. Administrative and National Policy Requirements Grantees are subject to the requirements in 45 CFR part 74 (nongovernmental) or 45 CFR part 92 (governmental). Direct Federal grants, sub-award funds, or contracts under this ACF program shall not be used to support inherently religious activities such as religious instruction, worship, or proselytization. Therefore, organizations must take steps to separate, in time or location, their inherently religious activities from the services funded under this program. Regulations pertaining to the Equal Treatment for Faith-Based Organizations, which includes the prohibition against Federal funding of inherently religious activities, can be found at the HHS Web site at https://www.os.dhhs.gov/fbci/ waisgate21.pdf. Faith-based and community organizations may reference the ‘‘Guidance to Faith-Based and Community Organizations on Partnering with the Federal Government’’ at https://www.whitehouse.gov/ government/fbci/guidance/. 3. Reporting Requirements Grantees will be required to submit program progress and financial reports (SF–269 found at https:// www.acf.hhs.gov/programs/ofs/ forms.htm) throughout the project period. Program progress and financial reports are due 30 days after the PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 9357 reporting period. Final programmatic and financial reports are due 90 days after the close of the project period. Program Progress Reports: Quarterly. Financial Reports: Quarterly. VII. Agency Contacts Program Office Contact Margaret Schaefer, Administration for Children and Families, Administration on Developmental Disabilities, 370 L’Enfant Promenade, SW., Mail Stop HHH 405–D, Washington, DC 20447. Phone: 202–690–5962. Fax: 202–205– 8037. E-mail: mschaefer@acf.hhs.gov. Grants Management Office Contact Tim Chappelle, Administration for Children and Families, Office of Grants Management, 370 L’Enfant Promenade, SW., Washington, DC 20447. Phone: 202–401–4855. E-mail: tichappelle@acf.hhs.gov. VIII. Other Information Additional information about this program and its purpose can be located on the following Web sites: https:// www.acf.hhs.gov/programs/add and https://www.nass.org. Dated: February 13, 2006. Patricia A. Morrissey, Commissioner, Administration on Developmental Disabilities. [FR Doc. E6–2515 Filed 2–22–06; 8:45 am] BILLING CODE 4184–01–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: 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. 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 April 25 and 26, 2006, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD, 301– 977–8900. Contact Person: Cathy Groupe, Center for Drug Evaluation and Research (HFD– E:\FR\FM\23FEN1.SGM 23FEN1 rwilkins on PROD1PC63 with NOTICES 9358 Federal Register / Vol. 71, No. 36 / Thursday, February 23, 2006 / Notices 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827–7001, e-mail: Cathy.Groupe@fda.hhs.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: On April 25, 2006, the committee will meet between 8 a.m. to 5 p.m., to discuss new drug application (NDA) 21–359 CELLEGESIC (nitroglycerin [NTG] ointment), 0.4% intra-anal, Cellegy Pharmaceuticals, Inc., for the proposed indication of relief of pain associated with anal fissures. On April 26, 2006, the committee will meet between 8 a.m. to 12 noon, to discuss the agency’s draft recommendations for relabeling of antihypertensive drugs for outcome claims, as a followup to the committee’s meeting on June 15, 2005, where the committee discussed class labeling of antihypertensive drugs based on the proximity of their data to outcome trials. Following this, from approximately 1 p.m. to 5 p.m., the committee will discuss the ‘‘Placebo in Hypertension Adverse Reaction MetaAnalysis’’ Study, a meta-analysis of more than 80,000 patients in placebocontrolled trials of antihypertensive medications, which evaluated the risk of irreversible harm in conducting placebo-controlled trials in patients with 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/orhms/dockets/ac/ acmenu.htm under the heading ‘‘Cardiovascular and Renal Drugs Advisory Committee.’’ (Click on the year 2006 and scroll down to the above named committee). 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 April 14, 2006. On April 25, 2006, oral presentations from the public will be scheduled between approximately 8:15 a.m. to 8:45 a.m. On April 26, 2006, oral presentations from the public will be scheduled between approximately 8:15 a.m. to 8:45 a.m. and 1 p.m. to 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 14, 2006, 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 VerDate Aug<31>2005 16:15 Feb 22, 2006 Jkt 205001 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 John Lauttman at least 7 days in advance of the meeting at 301–827–7001. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 15, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–2542 Filed 2–22–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES In the Federal Register of January 27, 2006, FDA announced that a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee would be held on March 7, 2006, from 8 a.m. to 5 p.m., and the open public hearing portion scheduled between approximately 1 p.m. and 2 p.m. On page 4593, in the third column, the Date and Time portion of the document is amended to read as follows: Date and Time: The meeting will be held on March 7 and 8, 2006, from 8 a.m. to 5 p.m. On page 4594, in the first column, in the Procedure portion of the document, the third sentence is amended to read as follows: Procedure: Oral presentations from the public will be scheduled between approximately 1 p.m. and 5 p.m. on March 7, 2006. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. SUPPLEMENTARY INFORMATION: Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee; Amendment of Notice Dated: February 15, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–2541 Filed 2–22–06; 8:45 am] BILLING CODE 4160–01–S AGENCY: Food and Drug Administration, HHS. ACTION: Notice. National Institutes of Health The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. This meeting was announced in the Federal Register of January 27, 2006 (71 FR 4593). The amendment is being made to reflect a change in Date and Time and Procedure portions of the document. An additional day is being added to this meeting and the length of time allotted for the open public hearing portion is being extended. There are no other changes. FOR FURTHER INFORMATION CONTACT: Sohail Mosaddegh, 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, FAX: 301–827– 6776, e-mail: sohail.mosaddegh@fda.hhs.gov, or the FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area), code 3014512543. Please call the Information Line for up-to-date information on this meeting. PO 00000 Frm 00051 Fmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4703 National Institute of Environmental Health Sciences; Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type of Information Collection Request: Revision of OMB No. 0925–0522 and expiration date 31 July 2006. Need and Use of Information Collection: The purpose of the Sister Study is to study genetic and environmental risk factors for the E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 71, Number 36 (Thursday, February 23, 2006)]
[Notices]
[Pages 9357-9358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2542]


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

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.
    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 April 25 and 26, 2006, 
from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD, 301-977-8900.
    Contact Person: Cathy Groupe, Center for Drug Evaluation and 
Research (HFD-

[[Page 9358]]

21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-
7001, e-mail: Cathy.Groupe@fda.hhs.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: On April 25, 2006, the committee will meet between 8 a.m. 
to 5 p.m., to discuss new drug application (NDA) 21-359 CELLEGESIC 
(nitroglycerin [NTG] ointment), 0.4% intra-anal, Cellegy 
Pharmaceuticals, Inc., for the proposed indication of relief of pain 
associated with anal fissures. On April 26, 2006, the committee will 
meet between 8 a.m. to 12 noon, to discuss the agency's draft 
recommendations for relabeling of antihypertensive drugs for outcome 
claims, as a followup to the committee's meeting on June 15, 2005, 
where the committee discussed class labeling of antihypertensive drugs 
based on the proximity of their data to outcome trials. Following this, 
from approximately 1 p.m. to 5 p.m., the committee will discuss the 
``Placebo in Hypertension Adverse Reaction Meta-Analysis'' Study, a 
meta-analysis of more than 80,000 patients in placebo-controlled trials 
of antihypertensive medications, which evaluated the risk of 
irreversible harm in conducting placebo-controlled trials in patients 
with 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/orhms/dockets/ac/acmenu.htm under the 
heading ``Cardiovascular and Renal Drugs Advisory Committee.'' (Click 
on the year 2006 and scroll down to the above named committee).
    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 April 14, 
2006. On April 25, 2006, oral presentations from the public will be 
scheduled between approximately 8:15 a.m. to 8:45 a.m. On April 26, 
2006, oral presentations from the public will be scheduled between 
approximately 8:15 a.m. to 8:45 a.m. and 1 p.m. to 1:30 p.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before April 
14, 2006, 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 John Lauttman at 
least 7 days in advance of the meeting at 301-827-7001.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 15, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-2542 Filed 2-22-06; 8:45 am]
BILLING CODE 4160-01-S

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