Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 38967-38968 [05-13206]

Download as PDF Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices 38967 part 92 (governmental) as well as 45 CFR part 87. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES 3. Reporting Requirements Administration for Children and Families Food and Drug Administration Program Progress Reports: SemiAnnually. Financial Reports: Semi-Annually. Grantees will be required to submit program progress reports and financial reports (SF269) throughout the project period. Program progress and financial reports are due 30 days after the reporting period. In addition, final programmatic and financial reports are due 90 days after the close of the project period. VII. Agency Contacts Notice of Correction for Services to Unaccompanied Alien Children Services (UAC) Program To Provide Temporary Shelter Care and Other Related Services to Children in Office of Refugee Resettlement (ORR) Custody Office of Refugee Resettlement (ORR), Administration for Children and Families, ACF, DHHS. ACTION: Notice of Correction. AGENCY: Peter Thompson, Grants Officer, Administration for Children and Families, Children’s Bureau, 330 C Street, SW., Room 2070, Washington, DC 20447, Phone: 202–401–4608, Email: pathompson@acf.hhs.gov. Funding Opportunity Title: Services to Unaccompanied Alien Children. Funding Opportunity Number: HHS– 2005–ACF–ORR–ZU–0007. SUMMARY: This notice is to inform interested parties of a clarification made to Services to Unaccompanied Alien Children funding announcement published on Monday, June 17, 2005. The following clarifications should be noted: Section I, Group I, Chart I on Page # 32345: VIII. Other Information Group I.—Geographic Location Program Office Contact John Gaudiosi, Children’s Bureau, 330 C Street, SW., Washington, DC 20447, Phone: 202–205–8625, E-mail: jgaudiosi@acf.hhs.gov. Grants Management Office Contact Notice: Beginning with FY 2006, the Administration for Children and Families (ACF) will no longer publish grant announcements in the Federal Register. Beginning October 1, 2005 applicants will be able to find a synopsis of all ACF grant opportunities and apply electronically for opportunities via: https:// www.Grants.gov. Applicants will also be able to find the complete text of all ACF grant announcements on the ACF Web site located at: https://www.acf.hhs.gov/ grants/. Additional information about this program and its purpose can be located on the following Web sites: https:// www.acf.hhs.gov/programs/cb/. For general questions regarding this announcement please contact: ACYF Operations Center, The Dixon Group ATTN: Children’s Bureau, 118 Q Street, NE., Washington DC 20002–2132, Telephone: 866–796–1591. Applicants will not be sent acknowledgements of received applications. Dated: June 28, 2005. Joan E. Ohl, Commissioner, Administration on Children, Youth and Families. [FR Doc. 05–13303 Filed 7–5–05; 8:45 am] BILLING CODE 4184–01–P VerDate jul<14>2003 16:35 Jul 05, 2005 No. 14, Up to 120 suitability assessment cases per applicant (two awards available) $1.9 million (for a total of $3.8 million for this category). Group II.—Geographic Location No. 1, Los Angeles, Basic Shelter and/ or Group Homes, 24 beds $1.76 million. Section II. Award Information on Page #32350 stated the following: ‘‘Floor on Amount of Individual Awards: $3,300,000 per budget period.’’ Section I, Group I, Chart I on Page #32345 is replaced with: Group I.—Geographic Location ‘‘No. 14, Up to 120 suitability assessment cases per application (two awards available) $800,000 (for a total of $1.6 million for this category).’’ Group II.—Geographic Location ‘‘No. 1, Los Angeles, Basic Shelter and/or Group Homes, 24 beds $1.75 million.’’ Section II. Award Information on Page #32350 is replaced with: ‘‘Floor on Amount of Individual Awards: $218,000 per budget period.’’ Dated: June 28, 2005. Nguyen Van Hanh, Director, Office of Refugee Resettlement. [FR Doc. 05–13299 Filed 7–5–05; 8:45 am] BILLING CODE 4184–01–P Jkt 205001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 August 4, 2005, from 8 a.m. to 5 p.m. Location: Center for Drug Evaluation and Research (CDER) Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Anuja Patel, 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: patelA@cder.fda.gov, or 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. When available, background materials for this meeting will be posted 1 business day prior to the meeting on the FDA Web site at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to Peripheral and Central Nervous System Drugs Advisory Committee). Agenda: The committee will discuss new drug application (NDA) 21–645, proposed trade name MT100 (naproxen sodium and metoclopramide hydrochloride) Tablets, Pozen, Inc., for the proposed indication of acute treatment of migraine headache with or without aura. 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 July 22, 2005. Oral presentations from the public will be scheduled between approximately 1 E:\FR\FM\06JYN1.SGM 06JYN1 38968 Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices 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 July 22, 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 John Lauttman 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: June 23, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–13206 Filed 7–5–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Proposed Project: Toolkit Protocol for the Crisis Counseling Assistance and Training Program (CCP)—NEW The Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Mental Health Services (CMHS) will create a toolkit to be used for the purposes of collecting data on the Crisis Counseling Assistance and Training Program (CCP). The CCP provides supplemental funding to states and territories for individual and community crisis intervention services during a federal disaster. VerDate jul<14>2003 16:35 Jul 05, 2005 Jkt 205001 The CCP has provided disaster mental health services to millions of disaster survivors since its inception and, as a result of 30 years of accumulated expertise, it has become an important model for Federal response to a variety of catastrophic events. State CCPs, such as Project HOPE (after Hurricane Floyd in North Carolina), Project Heartland (in Oklahoma City after the Murrah Federal Building bombing), Project Liberty (in New York after 9/11), and Project Outreach for Recovery (after the Rhode Island nightclub fire) have primarily addressed the short-term mental health needs of communities through (a) outreach and public education, (b) individual and group counseling, and (c) referral. Outreach and public education serve primarily to normalize reactions and to engage people who might need further care. Crisis counseling assists survivors to cope with current stress and symptoms in order to return to predisaster functioning. Crisis counseling relies largely on ‘‘active listening,’’ and crisis counselors also provide psychoeducation (especially about the nature of responses to trauma) and help clients build coping skills. Crisis counseling typically continues no more than a few times. Because crisis counseling is timelimited, referral is the third important functions of CCPs. Counselors are expected to refer clients to formal treatment if the person has developed more serious psychiatric problems. Data about services delivered and users of services will be collected throughout the program period. The data will be collected via the use of a toolkit that relies on standardized forms. At the program level, the data will be entered quickly and easily into a cumulative database to yield summary tables for quarterly and final reports for the program. SAMHSA has confirmed the feasibility of using scanable forms for most purposes. Because the data will be collected in a consistent way from all programs, they can be uploaded into an ongoing national database that likewise provides CMHS with a way of producing summary reports of services provided across all programs funded. The components of the tool kit are listed and described below: • Encounter logs. These forms will document all services provided. Completion of these logs will be required by the crisis counselors. There will be three types of encounter logs: (1) Individual Crisis Counseling Services Encounter Log; (2) Group Encounter Log; and (3) Weekly Tally Sheet. » Individual Crisis Counseling Services Encounter Log. Crisis counseling is defined as an interaction PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 that lasts at least 15 minutes and involves participant disclosure. This form will be completed by the Crisis Counselor for each service recipient, defined as the person or persons who actively participated in the session (e.g., by verbally participating), not someone who is merely present. For families, crisis counselors will complete separate forms for all family members who are actively engaged in the visit. Information to be collected includes demographics, service characteristics, risk factors, and referral data. » Group Encounter Log. This form will be used to identify either a group crisis counseling encounter or a group public education encounter. A check at the top will identify the class of activities (i.e., counseling or education). This form will be completed by the Crisis Counselor for each group encounter. Information to be collected includes services characteristics, group identity and characteristics, and group activities. » Weekly Tally Sheet. This form will document brief educational and supportive encounters not captured on any other form. Information to be collected will include service characteristics, daily tallies and weekly totals for brief educational or supportive contacts and material distribution with no or minimal interaction. • Assessment and Referral Tool. This tool will provide descriptive information about intense users of services, defined as all individuals receiving a third or fifth individual crisis counseling visit. This tool will be used beginning three months postdisaster and will be completed by the crisis counselor for each individual who accesses individual crisis counseling a third or fifth time. • Participant Feedback. These surveys will be completed by and collected from a sample of service recipients, not every recipient. A time sampling approach (e.g., soliciting participation from all counseling encounters one week per quarter) will be used. Information to be collected includes satisfaction with services, perceived improvements in selffunctioning, types of exposure, and event reactions. • CCP Service Provider Feedback. These surveys will be completed by and collected from the CCP service providers anonymously at six months and one year postevent. The survey will be coded on several program-level as well as worker-level variables. However, the program itself will be identified and shared with program management only if the number of individual workers is greater than 20. E:\FR\FM\06JYN1.SGM 06JYN1

Agencies

[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38967-38968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 August 4, 2005, from 8 
a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research (CDER) Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Anuja Patel, 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: patelA@cder.fda.gov, or 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. When available, 
background materials for this meeting will be posted 1 business day 
prior to the meeting on the FDA Web site at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to 
Peripheral and Central Nervous System Drugs Advisory Committee).
    Agenda: The committee will discuss new drug application (NDA) 21-
645, proposed trade name MT100 (naproxen sodium and metoclopramide 
hydrochloride) Tablets, Pozen, Inc., for the proposed indication of 
acute treatment of migraine headache with or without aura.
    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 July 22, 2005. 
Oral presentations from the public will be scheduled between 
approximately 1

[[Page 38968]]

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 July 22, 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 John Lauttman 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: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13206 Filed 7-5-05; 8:45 am]
BILLING CODE 4160-01-S

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