Advisory Commission on Childhood Vaccines; Notice of Meeting, 29143-29144 [2013-11777]

Download as PDF wreier-aviles on DSK5TPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Notices 796–9001, FAX: 301–847–8533, email: AADPAC@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 July 17, 2013, the committee will discuss the safety and efficacy for the new drug application (NDA) 203077, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, submitted by QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids. 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 July 2, 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 June 24, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to VerDate Mar<15>2010 15:20 May 16, 2013 Jkt 229001 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 June 25, 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 Yvette Waples 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: May 13, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–11765 Filed 5–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92– 463), notice is hereby given of the following meeting: Name: Advisory Commission on Childhood Vaccines (ACCV). Date and Time: June 07, 2013, 10:00 a.m. to 4:00 p.m. EDT. Place: Audio Conference Call and Adobe Connect Pro. The ACCV will meet on Friday, June 07 from 10:00 a.m. to 4:00 p.m. (EDT). The public can join the meeting by: 1. (Audio Portion) Calling the conference phone number 800–369– 3104 and providing the following information: Leaders Name: Dr. Vito Caserta Password: ACCV PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 29143 2. (Visual Portion) Connecting to the ACCV Adobe Connect Pro Meeting using the following URL: https:// hrsa.connectsolutions.com/accv/ (copy and paste the link into your browser if it does not work directly, and enter as a guest). Participants should call and connect 15 minutes prior to the meeting in order for logistics to be set up. If you have never attended an Adobe Connect meeting, please test your connection using the following URL: https:// hrsa.connectsolutions.com/common/ help/en/support/meeting_test.htm and get a quick overview by following URL: http://www.adobe.com/go/ connectpro_overview. Call (301) 443–6634 or send an email to aherzog@hrsa.gov if you are having trouble connecting to the meeting site. Agenda: The agenda items for the June meeting will include, but are not limited to: updates from the Division of Vaccine Injury Compensation (DVIC), Department of Justice (DOJ), National Vaccine Program Office (NVPO), Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health), and Center for Biologics, Evaluation and Research (Food and Drug Administration). A draft agenda and additional meeting materials will be posted on the ACCV Web site (http:// www.hrsa.gov/vaccinecompensation/ accv.htm) prior to the meeting. Agenda items are subject to change as priorities dictate. Public Comment: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: Annie Herzog, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C–26, 5600 Fishers Lane, Rockville, MD 20857 or email: aherzog@hrsa.gov. Requests should contain the name, address, telephone number, email address, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by email, mail, or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the public comment period. Public participation and ability to comment will be limited to space and time as it permits. E:\FR\FM\17MYN1.SGM 17MYN1 29144 Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Notices For Further Information Contact: Anyone requiring information regarding the ACCV should contact Annie Herzog, DVIC, HSB, HRSA, Room 11C–26, 5600 Fishers Lane, Rockville, MD 20857; Telephone (301) 443–6593 or email: aherzog@hrsa.gov. Dated: May 13, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–11777 Filed 5–16–13; 8:45 am] BILLING CODE 4165–15–P [FR Doc. 2013–11741 Filed 5–16–13; 8:45 am] Dated: May 13, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health [FR Doc. 2013–11738 Filed 5–16–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings National Institutes of Health wreier-aviles on DSK5TPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Neurological Sciences Training Initial Review Group Neurological Sciences and Disorders B. Date: June 20–21, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Avenue Crowne Plaza Chicago, 160 E. Huron Street, Chicago, IL 60611. Contact Person: Birgit Neuhuber, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS, NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529, neuhuber@ninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group; Neurological Sciences and Disorders A. Date: June 26–27, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Natalia Strunnikova, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS, NIH, NSC, 6001 Executive VerDate Mar<15>2010 15:20 May 16, 2013 Jkt 229001 Dated: May 13, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–402–0288, Natalia.Strunnikova@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Arthritis and Musculoskeletal and Skin Diseases Special Emphasis Panel; Ancillary Studies to Large Clinical Projects Grant Review. Date: June 7, 2013. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Democracy Boulevard, Suite 800, Bethesda, MD 20892. Contact Person: Xincheng Zheng, MD, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Arthritis, Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard, Suite 800, Bethesda, MD 20892, 301–594–4953, xincheng.zheng@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS) PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Vascular and Hematology Integrated Review Group Atherosclerosis and Inflammation of the Cardiovascular System Study Section. Date: June 10–11, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Katherine M Malinda, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, 301–435– 0912, Katherine_Malinda@csr.nih.gov. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group Biomedical Computing and Health Informatics Study Section. Date: June 12, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Melinda Jenkins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3156, MSC 7770, Bethesda, MD 20892, 301–437– 7872, jenkinsml2@mail.nih.gov. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group Nursing and Related Clinical Sciences Study Section. Date: June 12, 2013. Time: 8:00 a.m. to 6:00 p.m. E:\FR\FM\17MYN1.SGM 17MYN1

Agencies

[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Notices]
[Pages 29143-29144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11777]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the 
following meeting:

    Name: Advisory Commission on Childhood Vaccines (ACCV).
    Date and Time: June 07, 2013, 10:00 a.m. to 4:00 p.m. EDT.
    Place: Audio Conference Call and Adobe Connect Pro.
    The ACCV will meet on Friday, June 07 from 10:00 a.m. to 4:00 p.m. 
(EDT). The public can join the meeting by:
    1. (Audio Portion) Calling the conference phone number 800-369-3104 
and providing the following information:
    Leaders Name: Dr. Vito Caserta
    Password: ACCV
    2. (Visual Portion) Connecting to the ACCV Adobe Connect Pro 
Meeting using the following URL: https://hrsa.connectsolutions.com/accv/ (copy and paste the link into your browser if it does not work 
directly, and enter as a guest). Participants should call and connect 
15 minutes prior to the meeting in order for logistics to be set up. If 
you have never attended an Adobe Connect meeting, please test your 
connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm and get a quick overview by 
following URL: http://www.adobe.com/go/connectpro_overview.
    Call (301) 443-6634 or send an email to aherzog@hrsa.gov if you are 
having trouble connecting to the meeting site.
    Agenda: The agenda items for the June meeting will include, but are 
not limited to: updates from the Division of Vaccine Injury 
Compensation (DVIC), Department of Justice (DOJ), National Vaccine 
Program Office (NVPO), Immunization Safety Office (Centers for Disease 
Control and Prevention), National Institute of Allergy and Infectious 
Diseases (National Institutes of Health), and Center for Biologics, 
Evaluation and Research (Food and Drug Administration). A draft agenda 
and additional meeting materials will be posted on the ACCV Web site 
(http://www.hrsa.gov/vaccinecompensation/accv.htm) prior to the 
meeting. Agenda items are subject to change as priorities dictate.
    Public Comment: Persons interested in providing an oral 
presentation should submit a written request, along with a copy of 
their presentation to: Annie Herzog, DVIC, Healthcare Systems Bureau 
(HSB), Health Resources and Services Administration (HRSA), Room 11C-
26, 5600 Fishers Lane, Rockville, MD 20857 or email: aherzog@hrsa.gov. 
Requests should contain the name, address, telephone number, email 
address, and any business or professional affiliation of the person 
desiring to make an oral presentation. Groups having similar interests 
are requested to combine their comments and present them through a 
single representative. The allocation of time may be adjusted to 
accommodate the level of expressed interest. DVIC will notify each 
presenter by email, mail, or telephone of their assigned presentation 
time. Persons who do not file an advance request for a presentation, 
but desire to make an oral statement, may announce it at the time of 
the public comment period. Public participation and ability to comment 
will be limited to space and time as it permits.

[[Page 29144]]

    For Further Information Contact: Anyone requiring information 
regarding the ACCV should contact Annie Herzog, DVIC, HSB, HRSA, Room 
11C-26, 5600 Fishers Lane, Rockville, MD 20857; Telephone (301) 443-
6593 or email: aherzog@hrsa.gov.

    Dated: May 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-11777 Filed 5-16-13; 8:45 am]
BILLING CODE 4165-15-P