Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting., 12762-12763 [2013-04141]

Download as PDF 12762 Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices term ‘‘release agent’’ referred to an agent used to facilitate the release of foods from food contact surfaces, where the agent has been applied directly to the food contact surface, rather than incorporated into the food. In that guidance, we also stated our intention to reconsider our enforcement priorities with regard to the labeling of lecithin derived from soy used as a component of a release agent approximately 18 months after the issuance of the guidance. Further, we stated our expectation that, during the period in which we considered the exercise of our enforcement discretion, manufacturers of foods that use lecithin derived from soy as a component of a release agent would revise as necessary the labels of their relevant food products to comply with FALCPA and begin to label their products using the FALCPA-compliant labels by the end of the enforcement discretion period. We believe that there has been sufficient time for all manufacturers of foods that use lecithin derived from soy as a component of a release agent to revise the labels for such foods to be consistent with the requirements of section 403(w) of the FD&C Act. Therefore, we no longer believe it is appropriate to consider the exercise of our enforcement discretion with regard to foods that use lecithin derived from soy as a component of a release agent. For these reasons, we are withdrawing the April 2006 guidance entitled ‘‘Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act.’’ Dated: February 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04251 Filed 2–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] mstockstill on DSK4VPTVN1PROD with NOTICES Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic 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. VerDate Mar<15>2010 17:22 Feb 22, 2013 Jkt 229001 Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic Drugs 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 May 3, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Diane Goyette, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31–2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: MIDAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). 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 at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On May 3, 3013, the committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE, (sargramostim, Genzyme, Inc.), and 125294, TBO–FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs. 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 http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting 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 April 19, 2013. 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 April 11, 2013. 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 April 12, 2013. 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 Diane Goyette 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 http://www.fda.gov/Advisory E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices learn about possible modifications before coming to the meeting. Agenda: On Thursday, March 14, 2013, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107–109) and the for Dated: February 19, 2013. Pediatric Research Equity Act (Public Jill Hartzler Warner, Law 108–155) for: ACTEMRA Acting Associate Commissioner for Special (tocilizumab), ALIMTA (Pemetrexed Medical Programs. disodium), CREON (pancrelipase), [FR Doc. 2013–04141 Filed 2–22–13; 8:45 am] GADAVIST (gadobutrol), HIZENTRA BILLING CODE 4160–01–P [Immune Globulin Subcutaneous (Human), 20% Liquid], INOMAX (nitric oxide), INVEGA (paliperidone), DEPARTMENT OF HEALTH AND KEDBUMIN (albumin human), KYTRIL HUMAN SERVICES Injection (granisetron hydrochloride), LAMICTAL XR (lamotrigine), Food and Drug Administration MENACTRA [Meningococcal (Groups A, C, Y and W–135) Polysaccharide [Docket No. FDA–2013–N–0001] Diphtheria Toxoid Conjugate Vaccine], Pediatric Advisory Committee; Notice MOXEZA (moxifloxacin ophthalmic of Meeting solution 0.5%), NATROBA (spinosad), NEXIUM (esomeprazole magnesium), AGENCY: Food and Drug Administration, NEXIUM IV (esomeprazole sodium), HHS. UROXATRAL (alfuzosin ACTION: Notice. hydrochloride), and ZENPEP (pancrelipase). Also, there will be an This notice announces a forthcoming Informational Update on Codeine. meeting of a public advisory committee FDA intends to make background of the Food and Drug Administration material available to the public no later (FDA). The meeting will be open to the than 2 business days before the meeting. public. If FDA is unable to post the background Name of Committee: Pediatric material on its Web site prior to the Advisory Committee. meeting, the background material will General Function of the Committee: be made publicly available at the To provide advice and location of the advisory committee recommendations to the Agency on meeting, and the background material FDA’s regulatory issues. will be posted on FDA’s Web site after Date and Time: The meeting will be the meeting. Background material is held on Thursday, March 14, 2013 from available at http://www.fda.gov/ 8 a.m. to 5:30 p.m. AdvisoryCommittees/Calendar/ Location: Sheraton Silver Spring default.htm. Scroll down to the Hotel, 8777 Georgia Ave., Silver Spring, appropriate advisory committee meeting MD 20910, 301–589–0800 or visit the link. hotel’s Web site at http:// Procedure: Interested persons may www.sheratonsilverspring.com/. present data, information, or views, Contact Person: Walter Ellenberg, orally or in writing, on issues pending Office of the Commissioner, Food and before the committee. Written Drug Administration, 10903 New submissions may be made to the contact Hampshire Ave., Bldg. 32, rm. 5154, person on or before March 7, 2013. Oral Silver Spring, MD 20993, 301–796– presentations from the public will be 0885, email walter.ellenberg@ scheduled between approximately 11:30 fda.hhs.gov or FDA Advisory Committee a.m. and 12:30 p.m. Those individuals Information Line, 1–800–741–8138 interested in making formal oral (301–443–0572 in the Washington, DC presentations should notify the contact area). A notice in the Federal Register person and submit a brief statement of about last minute modifications that the general nature of the evidence or arguments they wish to present, the impact a previously announced names and addresses of proposed advisory committee meeting cannot participants, and an indication of the always be published quickly enough to approximate time requested to make provide timely notice. Therefore, you their presentation on or before February should always check the Agency’s Web 27, 2013. Time allotted for each site at http://www.fda.gov/ presentation may be limited. If the AdvisoryCommittees/default.htm and number of registrants requesting to scroll down to the appropriate advisory speak is greater than can be reasonably committee meeting link, or call the accommodated during the scheduled advisory committee information line to mstockstill on DSK4VPTVN1PROD with NOTICES Committees/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). VerDate Mar<15>2010 17:22 Feb 22, 2013 Jkt 229001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 12763 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 February 28, 2013. 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 Walter Ellenberg at 301–796–0885, email walter.ellenberg@fda.hhs.gov, 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 http://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: February 19, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–04256 Filed 2–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Fecal Microbiota for Transplantation; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), are announcing a public workshop entitled ‘‘Fecal Microbiota for Transplantation.’’ The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with fecal microbiota for transplantation (FMT). E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12762-12763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Joint Meeting of the Medical Imaging Drugs Advisory Committee and 
the Oncologic 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 Committees: Medical Imaging Drugs Advisory Committee and 
the Oncologic Drugs 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 May 3, 2013, from 8 a.m. 
to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White 
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. Information regarding special accommodations due 
to a disability, visitor parking, and transportation may be accessed 
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the 
heading ``Resources for You,'' click on ``Public Meetings at the FDA 
White Oak Campus.'' Please note that visitors to the White Oak Campus 
must enter through Building 1.
    Contact Person: Diane Goyette, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, 
email: MIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On May 3, 3013, the committees will discuss the safety and 
efficacy of currently approved leukocyte growth factors (LGFs) as 
potential treatments for radiation-induced myelosuppression associated 
with a radiological/nuclear incident. (Myelosuppression is a reduction 
of blood cell production, which can be caused by radiation exposure.) 
Currently approved LGFs are licensed under biological license 
applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 
125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE, 
(sargramostim, Genzyme, Inc.), and 125294, TBO-FILGRASTIM (tbo-
filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and 
Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, 
based on treatment in an animal model of radiation-induced 
myelosuppression. Safety and other supportive information are currently 
described in the labeling for LGFs.
    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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
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 
April 19, 2013. 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 April 11, 2013. 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 April 12, 2013.
    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 Diane Goyette 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 http://www.fda.gov/Advisory

[[Page 12763]]

Committees/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: February 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04141 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P