Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 2677-2678 [2013-00507]

Download as PDF Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Notices III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: January 8, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–00474 Filed 1–11–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD with 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. DATES: Date and Time: The meeting will be held on February 12, 2013, from 8:30 a.m. to 5 p.m. Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville, MD 20857. For those unable to attend in person, the meeting will also be webcast. The webcast will be available at the following link: http://fda. yorkcast.com/webcast/Viewer/ ?peid=9e38bbbbc4ae4327ab89 5d98a845fdd11d. Contact Person: Bryan Emery or Pearline Muckelvene, Center for Biologics Evaluation and Research, HFM–71, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–1277 or 301–827–1281, 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 VerDate Mar<15>2010 16:53 Jan 11, 2013 Jkt 229001 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 February 12, 2013, the Committee will meet in open session to discuss Cangene’s biologics license application for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)(Equine) seeking licensure under FDA’s authority to approve a product based on evidence of safety in humans and effectiveness from studies in animals when human efficacy studies are not ethical or feasible. 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 February 5, 2013. On February 12, 2013, oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 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 January 28, 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 January 29, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. The PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 2677 link for the webcast will be available at 8 a.m. the morning of February 12, 2013. 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 Bryan Emery 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 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: January 8, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–00491 Filed 1–11–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management 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: Advisory Committee for Reproductive Health Drugs 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 March 5, 2013, from 8 a.m. to 4 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may E:\FR\FM\14JAN1.SGM 14JAN1 mstockstill on DSK4VPTVN1PROD with 2678 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Notices 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: Kalyani Bhatt, 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, email: ACRHD@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 http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On March 5, 2013, the committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increase the chance of having a broken bone) outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include: Miacalcin (calcitonin salmon) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin salmon recombinant) nasal spray, submitted by Upsher Smith Laboratories; and the generic equivalents of these products. 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 February 15, 2013. VerDate Mar<15>2010 16:53 Jan 11, 2013 Jkt 229001 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 February 7, 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 February 8, 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 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 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: January 8, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–00507 Filed 1–11–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request (60-Day FRN): The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation (NCI) In compliance with the requirement of Section 3506(c)(2)(A) of SUMMARY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To submit comments in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact: Erik Augustson, Ph.D., MPH, Behavioral Scientist/Health Science Administrator, Division of Cancer Control and Population Sciences, 6130 Executive Blvd., EPN– 4034, Bethesda, MD 20892–7337 or call non-toll-free number 301–435–7610 or Email your request, including your address to: augustse@mail.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation (NCI), 0925–NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for OMB to approve the new submission titled, ‘‘The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation’’ for 3 years. The supporting statements and various attachments accompany this memorandum. This study seeks to assess the efficacy of the SmokefreeTXT program, a text message smoking cessation intervention designed for young adult smokers ages 18–29. The SmokefreeTXT program is a component of a larger series of eHealth/ mHealth tobacco cessation intervention programs. SmokefreeTXT has been developed (and is managed) by the E:\FR\FM\14JAN1.SGM 14JAN1

Agencies

[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Pages 2677-2678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Joint Meeting of the Advisory Committee for Reproductive Health 
Drugs and the Drug Safety and Risk Management 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: Advisory Committee for Reproductive Health 
Drugs 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 March 5, 2013, from 8 
a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may

[[Page 2678]]

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: Kalyani Bhatt, 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, email: ACRHD@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 http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee link, or call the advisory committee information 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: On March 5, 2013, the committees will discuss whether the 
benefit of calcitonin salmon for the treatment of postmenopausal 
osteoporosis (thinning and weakening of bones that increase the chance 
of having a broken bone) outweighs a potential risk of cancer. 
Calcitonin salmon products approved for the treatment of osteoporosis 
include: Miacalcin (calcitonin salmon) injection and nasal spray, 
submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin 
salmon recombinant) nasal spray, submitted by Upsher Smith 
Laboratories; and the generic equivalents of these products.
    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 
February 15, 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 February 7, 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 February 8, 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 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 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: January 8, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-00507 Filed 1-11-13; 8:45 am]
BILLING CODE 4160-01-P