Science Board to the Food and Drug Administration; Notice of Meeting, 51031-51032 [2012-20782]

Download as PDF Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices tkelley on DSK3SPTVN1PROD with NOTICES The proposal also offered Dr. Shrum an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. The proposal was received on May 11, 2012. Dr. Shrum failed to respond and has, therefore, waived his opportunity for a hearing and has waived any contentions concerning his debarment (21 CFR part 12). Management between 9 a.m. and 4 p.m., Monday through Friday. II. Findings and Order Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Kelly Dean Shrum has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. As a result of the foregoing finding, Dr. Shrum is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see section 306(c)(1)(B) and (c)(2)(A)(ii) of the FD&C Act and section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Shrum in any capacity during Dr. Shrum’s debarment, will be subject to civil money penalties (section 307(a)(6) of the Act (21 U.S.C. 335b(a)(6))). If Dr. Shrum provides services in any capacity to a person with an approved or pending drug product application during his period of debarment he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act. In addition, FDA will not accept or review any abbreviated new drug applications from Dr. Shrum during his period of debarment (section 306(c)(1)(B) of the FD&C Act. Any application by Dr. Shrum for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA–2012–N–0246 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets [Docket No: FDA–2012–N–0001] VerDate Mar<15>2010 18:26 Aug 22, 2012 Jkt 226001 Dated: August 8, 2012. Armando Zamora, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2012–20784 Filed 8–22–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to the FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. DATES: Date and Time: The meeting will be held on Wednesday, October 3, 2012, from approximately 8:30 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm 1503), Silver Spring, MD 20993. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https:// collaboration.fda.gov/scienceboard/. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm, under the heading ‘‘Resources for You,’’ click PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 51031 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: Martha Monser, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301–796–4627, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ 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: The Science Board will be presented with a draft charge to establish a new subcommittee to evaluate the Agency’s continuing work to address the challenges identified in the Board’s 2007 ‘‘Science and Mission at Risk’’ Report. The Science Board will be provided with updates from the Center for Devices and Radiological Health Research Review subcommittee and the Global Health subcommittee. The Science Board will also hear progress updates on nanotechnology and the ongoing activities in the priority areas outlined in the Strategic Plan for Regulatory Science. Overviews of genomics activities at the National Center for Toxological Research and the Center for Biologics Evaluation and Research will be presented. Finally, the recipients of the FY2012 Scientific Achievement awards (selected by the Science Board) will provide overviews of the activities for which the awards were given. 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 E:\FR\FM\23AUN1.SGM 23AUN1 51032 Federal Register / Vol. 77, No. 164 / Thursday, August 23, 2012 / Notices tkelley on DSK3SPTVN1PROD with NOTICES 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 Wednesday, September 26, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 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 Tuesday, September 18, 2012. 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 Wednesday, September 19, 2012. 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 Martha Monser 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: August 17, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–20782 Filed 8–22–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:59 Aug 22, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; 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: National Cancer Institute Special Emphasis Panel, NCI Program Project Meeting II. Date: October 3–4, 2012, Time: 3:00 p.m. to 9:00 p.m. Agenda: To review and evaluate grant applications, Place: National Institutes of Health Neuroscience Center 6001 Executive Boulevard Room A1/A2 Rockville, MD 20852. Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH 6116 Executive Boulevard, Room 8139 Bethesda, MD 20892–8328, (301) 594–0114, ahmads@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Program Project Meeting III. Date: October 10–11, 2012. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road Bethesda, MD 20852. Contact Person: Jeannette F. Korczak, Ph.D., Scientific Review Officer Research Programs Review Branch Division Of Extramural Activities National Cancer Institute, NIH 6116 Executive Blvd., Room 8115 Bethesda, MD 20892 301–496–9767, korczakj@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Program Project Meeting IV. Date: October 15–16, 2012. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville 1750 Rockville Pike Rockville, MD 20852. Contact Person: Caterina Bianco, MD, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Cancer Institute, NIH 6116 Executive Blvd., Ste. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 8134 Bethesda, MD 20892–8328, 301–496– 7011, biancoc@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Program Project Meeting V. Date: October 18, 2012 Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Cancer Institute, 6116 Executive Boulevard, DEA Conference Room 8018, Rockville, MD 20852. Contact Person: Virginia P. Wray, Ph.D., Deputy Chief, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH 6116 Executive Blvd., Room 8125, Bethesda, MD 20892,–8328, 301–496–9236, wrayv@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS). Dated: August 17, 2012. Anna P. Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–20690 Filed 8–22–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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: Center for Scientific Review Special Emphasis Panel Member Conflict: Cancer and Lipids. E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51031-51032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20782]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No: FDA-2012-N-0001]


Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug 
Administration (Science Board).
    General Function of the Committee: The Science Board provides 
advice primarily to the Commissioner of Food and Drugs and other 
appropriate officials on specific complex scientific and technical 
issues important to the FDA and its mission, including emerging issues 
within the scientific community. Additionally, the Science Board 
provides advice to the Agency on keeping pace with technical and 
scientific developments including in regulatory science; and input into 
the Agency's research agenda; and on upgrading its scientific and 
research facilities and training opportunities. It will also provide, 
where requested, expert review of Agency-sponsored intramural and 
extramural scientific research programs.

DATES: Date and Time: The meeting will be held on Wednesday, October 3, 
2012, from approximately 8:30 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm 1503), Silver Spring, MD 
20993. For those unable to attend in person, the meeting will also be 
webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard/. Information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: https://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: Martha Monser, Office of the Chief Scientist, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301-796-
4627, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), to find out further information 
regarding FDA advisory committee information. 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 https://www.fda.gov/AdvisoryCommittees/Calendar/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: The Science Board will be presented with a draft charge to 
establish a new subcommittee to evaluate the Agency's continuing work 
to address the challenges identified in the Board's 2007 ``Science and 
Mission at Risk'' Report. The Science Board will be provided with 
updates from the Center for Devices and Radiological Health Research 
Review subcommittee and the Global Health subcommittee. The Science 
Board will also hear progress updates on nanotechnology and the ongoing 
activities in the priority areas outlined in the Strategic Plan for 
Regulatory Science. Overviews of genomics activities at the National 
Center for Toxological Research and the Center for Biologics Evaluation 
and Research will be presented. Finally, the recipients of the FY2012 
Scientific Achievement awards (selected by the Science Board) will 
provide overviews of the activities for which the awards were given.
    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

[[Page 51032]]

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 
Wednesday, September 26, 2012. Oral presentations from the public will 
be scheduled between approximately 1 p.m. and 1:30 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 
Tuesday, September 18, 2012. 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 
Wednesday, September 19, 2012.
    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 Martha Monser 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: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-20782 Filed 8-22-12; 8:45 am]
BILLING CODE 4160-01-P
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