Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 29766-29767 [2011-12543]

Download as PDF 29766 Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices The Food and Drug Administration (FDA) is reopening the comment period for the notice of public workshop published in the Federal Register of January 7, 2011 (76 FR 1182). In that notice, FDA announced a public workshop that took place on February 15 and 16, 2011, and requested public comment regarding the topics discussed at the workshop on determining system attributes for tracking and tracing prescription drugs. The workshop provided a forum for discussing possible approaches to developing a track-and-trace system and for obtaining input from supply chain partners on potential attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages. FDA is reopening the comment period to allow additional time for interested persons both to consider all the information provided by the Agency related to the workshop and to submit additional comments. DATES: Submit either electronic or written comments by June 22, 2011. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Connie Jung, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3100, connie.jung@fda.hhs.gov. SUPPLEMENTARY INFORMATION: srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: I. Background In the Federal Register of January 7, 2011 (76 FR 1182), FDA published a notice announcing a public workshop entitled ‘‘Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop.’’ In that notice, FDA requested the following: (1) Input and comments from interested stakeholders regarding possible approaches to developing a track-and-trace system and (2) input from supply chain partners on potential attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages. Interested persons were originally given until April 16, 2011, to submit comments. II. Request for Comments On April 4, 2011, FDA posted on the FDA Web site a summary of the main VerDate Mar<15>2010 16:22 May 20, 2011 Jkt 223001 comments shared by the public workshop participants. To allow adequate time for interested persons both to consider all the information provided by the Agency related to the workshop and to submit additional comments, FDA is reopening the comment period. III. How to Submit Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 13, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–12617 Filed 5–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Pulmonary-Allergy 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: PulmonaryAllergy 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 June 23, 2011, from 8:30 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel’s telephone number is 301– 589–5200. Contact Person: Kristine T. Khuc, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, e-mail: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 PADAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. 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 June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed trade name Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema. 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 June 16, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those individuals interested in making 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 June 8, 2011. 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 E:\FR\FM\23MYN1.SGM 23MYN1 Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices notify interested persons regarding their request to speak by June 9, 2011. 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 Kristine T. Khuc 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: May 16, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–12543 Filed 5–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. srobinson on DSK4SPTVN1PROD 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: Arthritis 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 June 21, 2011, from 8:30 a.m. to 4 p.m. Location: The Marriott Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd. East, Hyattsville, MD 20783. The hotel’s phone number is 301–985–7300. Contact Person: Philip A. Bautista, Center for Drug Evaluation and VerDate Mar<15>2010 16:22 May 20, 2011 Jkt 223001 Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, e-mail: AAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. 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 June 21, 2011, the committee will discuss the supplemental biologics license application 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corp., for the following proposed indication: ‘‘ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks.’’ 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 June 7, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making 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 May 27, 2011. Time allotted for each PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 29767 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 May 31, 2011. 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 Philip Bautista 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: May 16, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–12544 Filed 5–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0238] Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is announcing the opening of a docket to obtain information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. FDA is establishing this docket to provide an opportunity for interested parties to provide information and share views that will inform the development of guidance on preventive controls for food facilities that SUMMARY: E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29766-29767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Pulmonary-Allergy 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: Pulmonary-Allergy 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 June 23, 2011, from 8:30 
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD 20910. The hotel's telephone number 
is 301-589-5200.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: PADAC@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and 
follow the prompts to the desired center or product area. 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 June 23, 2011, the committee will discuss the new drug 
application (NDA) 22150, icatibant solution for injection (proposed 
trade name Firazyr), Shire Human Genetic Therapies, for the proposed 
indication of treatment of acute attacks of hereditary angioedema.
    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 June 
16, 2011. Oral presentations from the public will be scheduled between 
approximately 1 p.m. to 2 p.m. Those individuals interested in making 
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 June 8, 2011. 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

[[Page 29767]]

notify interested persons regarding their request to speak by June 9, 
2011.
    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 Kristine T. Khuc 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: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12543 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P

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