Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting, 32620-32621 [E9-16136]

Download as PDF 32620 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSKH9S0YB1PROD with NOTICES 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: Blood Products 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 July 20, 2009, from 8 a.m. to 6 p.m. and on July 21, 2009, from 9 a.m. to 12 noon. Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877, 301–977–8900. Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On July 20, 2009, in the morning, the committee will review proposed strategies to demonstrate the effectiveness of new coral snake antivenoms. In the afternoon, the committee will discuss alternative clinical and surrogate endpoints for evaluating efficacy of Alpha-1 Proteinase Inhibitor (Human) augmentation therapy in Alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic condition associated with decreased circulating levels of alpha-1 antitrypsin that significantly increases the risk of VerDate Nov<24>2008 17:23 Jul 07, 2009 Jkt 217001 serious lung disease (i.e. emphysemia) in adults. On July 21, 2009, the committee will hear updates on the following topics: The April 30 to May 1, 2009, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability (https://www.hhs.gov/ophs/ bloodsafety/); the June 12, 2009, meeting of the FDA Transmissible Spongiform Encephalopathies Advisory Committee (https://www.fda.gov/ AdvisoryCommittees/Committees MeetingMaterials/BloodVaccinesand OtherBiologics/Transmissible SpongiformEncephalopathiesAdvisory Committee/ucm129559.htm); and an overview of the epidemiology and virology of the 2009 A/H1N1 influenza virus and its impact on the U.S. blood system. The committee will also hear informational presentations on recent public and private hemovigilance efforts, including the pilot hemovigilance module in the National Healthcare Safety Network. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm, scroll down to the appropriate advisory committee link. 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 on or before July 15, 2009. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11 a.m. and between approximately 3:45 p.m. and 5 p.m. on July 20, 2009, and between approximately 11:30 a.m. and 12 noon on July 21, 2009. Those desiring to make formal oral presentations should notify the contact person 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 on or before July 13, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 8, 2009. 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 William Freas or Pearline K. Muckelvene at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. FDA regrets that it was unable to publish this notice 15 days prior to the July 20, 2009, Blood Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Blood Advisory Committee were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 29, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–16101 Filed 7–7–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; 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. E:\FR\FM\08JYN1.SGM 08JYN1 mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices Name of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. 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 August 5, 2009, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589– 5200. Contact Person: Paul Tran, 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: paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will: (1) Receive a status update from the Office of Generic Drugs (OGD) on bioequivalence for highly variable drugs (highly variable means that the rate and amount of the drug entering blood varies significantly from one administration to another); (2) receive presentations from the Office of Pharmaceutical Science (OPS) on the scientific and regulatory challenges of Transdermal Drug Delivery Systems (TDDS); (3) receive presentations from OPS and discuss current thinking on ‘‘Classifying Pre-Surgical Preparations as Sterile Products’’ in consideration of how these products are used; and (4) be updated by OPS on the current status of the International Conference on Harmonization (ICH) Quality Topics [i.e., those relating to chemical and pharmaceutical quality assurance (stability testing, impurity testing, etc.)], and outline the role of the ICH Implementation Work Group (Q IWG), its future activities, and any remaining gaps and challenges. FDA intends to make background material available to the public no later than 2 business days before the meeting. VerDate Nov<24>2008 17:23 Jul 07, 2009 Jkt 217001 If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm, click on the year 2009 and scroll down to the appropriate advisory committee link. 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 on or before July 21, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person 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 on or before July 13, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 14, 2009. 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 Paul Tran at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 32621 Dated: June 29, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–16136 Filed 7–7–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Office of Clinical and Preventive Services; Division of Behavioral Health; the Methamphetamine & Suicide Prevention Initiative for American Indian and Alaska Native Urban Programs Announcement Type: New. Funding Announcement Number: HHS–2009–IHS–METHU–0002. Catalog of Federal Domestic Assistance Number(s): 93.933. Key Dates: Application Deadline Date: July 31, 2009. Review Date: August 6–7, 2009. Earliest Anticipated Start Date: August 14, 2009. Table of Contents I. Funding Opportunity II. Award Information III. Eligibility IV. Application & Submission Information V. Application Review Information VI. Award Administration Information VII. Agency Contacts VIII. Other Information I. Funding Opportunity Description The Indian Health Service (IHS) announces competitive grant applications for the Methamphetamine & Suicide Prevention Initiative (MSPI) for American Indian and Alaska Native (AI/AN) Urban Program communities. This program is authorized under the Snyder Act, 25 U.S.C. 13, and 25 U.S.C. 1602(a)(b)(9)(11)(12) of the Indian Health Care Improvement Act (IHCIA), as amended. This program is described at 93.933 in the Catalog of Federal Domestic Assistance. The purpose of the MSPI–U is to expand community-level access to effective, Urban AI/AN methamphetamine and/or suicide prevention and treatment programs. Resources will enhance evidence-based or practice-based methamphetamine and/or suicide prevention or treatment programs and/or community mobilization programs. The methamphetamine and suicide prevention or treatment funding will be used to: • Provide community-focused responses that enhance evidence-based or practice based methamphetamine and/or suicide prevention or treatment services or education programming; E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Notices]
[Pages 32620-32621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16136]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology; 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.

[[Page 32621]]

    Name of Committee: Advisory Committee for Pharmaceutical Science 
and Clinical Pharmacology.
    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 August 5, 2009, from 8 a.m. 
to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
    Contact Person: Paul Tran, 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: paul.tran@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572) in the 
Washington, DC area), code 3014512539. Please call the Information Line 
for up-to-date information on this meeting. A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: The committee will: (1) Receive a status update from the 
Office of Generic Drugs (OGD) on bioequivalence for highly variable 
drugs (highly variable means that the rate and amount of the drug 
entering blood varies significantly from one administration to 
another); (2) receive presentations from the Office of Pharmaceutical 
Science (OPS) on the scientific and regulatory challenges of 
Transdermal Drug Delivery Systems (TDDS); (3) receive presentations 
from OPS and discuss current thinking on ``Classifying Pre-Surgical 
Preparations as Sterile Products'' in consideration of how these 
products are used; and (4) be updated by OPS on the current status of 
the International Conference on Harmonization (ICH) Quality Topics 
[i.e., those relating to chemical and pharmaceutical quality assurance 
(stability testing, impurity testing, etc.)], and outline the role of 
the ICH Implementation Work Group (Q IWG), its future activities, and 
any remaining gaps and challenges.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm, click on the year 2009 and scroll down to the appropriate 
advisory committee link.
    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 on or before July 
21, 2009. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Those desiring to make formal oral 
presentations should notify the contact person 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 
on or before July 13, 2009. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by July 14, 
2009.
    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 Paul Tran at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-16136 Filed 7-7-09; 8:45 am]
BILLING CODE 4160-01-S

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