Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice, 42906-42907 [E9-20377]

Download as PDF 42906 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices Provider Integration Subcommittee will meet at Sutter Amador Hospital in Jackson, California. The Home-Based Care Options for Seniors Subcommittee will meet at Madelyn Helling Library in Nevada City, California. The Subcommittees will return to the Sheraton Grand Hotel in Sacramento at 4 p.m. Transportation to the site visits will not be provided to the public. The Thursday meeting will close at 4 p.m. The final session will be convened on Friday morning at 8:45 a.m. The meeting will open with a review of the Subcommittee site visits. The staff of the Office of Rural Health Policy will provide an update on the Department of Health and Human Services. The Committee will draft a letter to the Secretary or Designee and discuss the February 2010 meeting. The meeting will be adjourned at 11 a.m. For Further Information Contact: Anyone requiring information regarding the Committee should contact Jennifer Chang, MPH, 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 Michele Pray Gibson, Office of Rural Health Policy (ORHP), Telephone (301) 443–0835. The Committee meeting agenda will be posted on ORHP’s Web site https://www.ruralhealth.hrsa.gov. Dated: August 19, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–20342 Filed 8–24–09; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting pwalker on DSK8KYBLC1PROD with NOTICES 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). At least one portion of the meeting will be closed to the public. VerDate Nov<24>2008 22:52 Aug 24, 2009 Jkt 217001 Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 24, 2009, from 8 a.m. to 4:30 p.m. Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD. The hotel phone number is 301–948–8900. Contact Person: Kalyani Bhatt, 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: Kalyani.Bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741– 8138 (301–443–0572 in the Washington, DC area), codes 3014512529 or 3014512535. Please call the Information Line for up-todate 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 September 24, 2009, the committees will begin with a closed session from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. The committees will discuss new drug application (NDA) 22–272, OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. This formulation was previously reviewed and discussed by these committees on May 5, 2008, and will be considered again in light of new data. 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 a https:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: On September 24, 2009, from 9:15 a.m. to 4:30 p.m., the meeting is open to the public. 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 September 10, 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 September 1, 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 September 2, 2009. Closed Presentation of Data: On September 24, 2009, from 8 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The meeting will be closed to permit discussion of confidential information regarding detailed protocols to evaluate the formulation of the drug product. 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 Kalyani Bhatt 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/AboutAdvisory Committees/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: August 19, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–20376 Filed 8–24–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal E:\FR\FM\25AUN1.SGM 25AUN1 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices Register of August 11, 2009 (74 FR 40207). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: Kalyani.Bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area), codes 3014512529 or 3014512535. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of August 11, 2009, FDA announced that a meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would be held on September 23, 2009, from 8 a.m. to 4:30 p.m. On page 40207, in the second column, the Agenda portion of the document is changed to read as follows: Agenda: The committees will discuss new drug application (NDA) 21–217, EXALGO (hydromorphone HC1), Neuromed Pharmaceuticals, Inc., a modified-release hydromorphone drug product indicated for the treatment of moderate-to-severe pain in opioidtolerant patients. 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. Dated: August 19, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–20377 Filed 8–24–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Oncologic Drugs Advisory Committee; Notice of Meeting pwalker on DSK8KYBLC1PROD with NOTICES 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. VerDate Nov<24>2008 22:52 Aug 24, 2009 Jkt 217001 Name of Committee: Oncologic 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 October 6, 2009, from 8 a.m. to 4 p.m. Location: Hilton Washington DC North/ Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301–977–8900. Contact Person: Nicole Vesely, 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– 827–6793, FAX: 301–827–6776, e-mail: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741– 8138 (301–443–0572 in the Washington, DC area), code 3014512542. 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 discuss new drug application (NDA) 021–825, proposed trade name FERRIPROX (deferiprone) filmcoated tablets and oral solution, manufactured by ApoPharma Inc. The proposed indications (uses) for this product is as an iron chelating agent, which is a drug that binds with iron in the body and helps to make elimination of iron easier, reducing iron build-up. There are two specific proposed indications (uses) of FERRIPROX: (1) the treatment of iron overload, or buildup in patients with transfusion-dependent thalassemia, an inherited blood disorder that necessitates frequent transfusion of normal blood which can lead to iron build-up due to the iron content in the blood a patient receives; and (2) for the treatment of iron overload in patients with other transfusiondependent anemias (other blood disorders that require frequent transfusions) for which the use of other iron chelating agents has been considered inappropriate. 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 September 21, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 42907 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 September 11, 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 September 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 Nicole Vesely 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/AboutAdvisory Committees/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: August 19, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–20378 Filed 8–24–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: Crew Member’s Declaration AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: 30–Day notice and request for comments; Revision of an existing information collection: 1651–0021. SUMMARY: U.S. Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Crew Member’s Declaration. This is a proposed extension and revision of an information collection that was E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42906-42907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20377]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Anesthetic and Life Support Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of a meeting of the Anesthetic and Life Support Drugs 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee. This meeting was announced in the Federal

[[Page 42907]]

Register of August 11, 2009 (74 FR 40207). The amendment is being made 
to reflect a change in the Agenda portion of the document. There are no 
other changes.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: 
Kalyani.Bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington DC area), codes 
3014512529 or 3014512535. Please call the Information Line for up-to-
date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 11, 2009, 
FDA announced that a meeting of the Anesthetic and Life Support Drugs 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee would be held on September 23, 2009, from 8 a.m. to 4:30 p.m. 
On page 40207, in the second column, the Agenda portion of the document 
is changed to read as follows:
    Agenda: The committees will discuss new drug application (NDA) 21-
217, EXALGO (hydromorphone HC1), Neuromed Pharmaceuticals, Inc., a 
modified-release hydromorphone drug product indicated for the treatment 
of moderate-to-severe pain in opioid-tolerant patients.
    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.

    Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20377 Filed 8-24-09; 8:45 am]
BILLING CODE 4160-01-S

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