Science Board to the Food and Drug Administration; Amendment of Notice, 59099-59100 [E7-20550]

Download as PDF Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Notices Dated: October 11, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–20512 Filed 10–17–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 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: Peripheral and Central Nervous System 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 December 6, 2007, from 8 a.m. to 5 p.m. Location: Sheraton College Park Hotel, The Ballroom, 4095 Powder Mill Rd., Beltsville, MD. The hotel telephone number is 301–937–4422. Contact Person: Darrell Lyons, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: darrell.lyons@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512543. 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: The committee will discuss new drug application (NDA) 21–894, tetrabenazine, Prestwick Pharmaceuticals, Inc., for the proposed indication to treat chorea associated with Huntington’s disease. VerDate Aug<31>2005 21:55 Oct 17, 2007 Jkt 214001 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and 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 November 21, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make 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 November 7, 2007. 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 November 8, 2007. 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 Darrell Lyons 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/oc/advisory/ default.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). PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 59099 Dated: October 11, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–20511 Filed 10–17–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration (Science Board). This meeting was originally announced in the Federal Register of October 2, 2007 (72 FR 56078). The amendment is being made to reflect a change in the Date and Time and Procedure portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: ˜ Carlos Pena, Office of the Commissioner, Food and Drug Administration (HF–33), 5600 Fishers Lane, Rockville, MD, 20857, 301–827– ˜ 6687, carlos.Pena@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512603. SUPPLEMENTARY INFORMATION: In the Federal Register of October 2, 2007, FDA announced that a meeting of the Science Board would be held on October 30, 2007. On page 56078, beginning in the second column, the Date and Time and Procedure portions of the document are amended to read as follows: Date and Time: The meeting will be held on December 3, 2007, from 8 a.m. to 5:30 p.m. 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 November 26, 2007. Oral presentations from the public will be scheduled between approximately 4 p.m. and 5 p.m. Those desiring to make 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 E:\FR\FM\18OCN1.SGM 18OCN1 59100 Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Notices or before November 16, 2007. 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 November 19, 2007. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: October 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–20550 Filed 10–17–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2007–0007] Collection of Information Under Review by Office of Management and Budget: OMB Control Number: 1625– 0106 Coast Guard, DHS. Sixty-day notice requesting comments. AGENCY: ACTION: In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) requesting an extension of their approval for the following collection of information: 1625–0106, Unauthorized Entry into Cuban Territorial Waters. Before submitting this ICR to OMB, the Coast Guard is inviting comments as described below. DATES: Comments must reach the Coast Guard on or before December 17, 2007. ADDRESSES: To make sure your comments and related material do not enter the docket [USCG–2007–0007] more than once, please submit them by only one of the following means: (1) Online: https:// www.regulations.gov. (2) Mail or Hand Deliver to: Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590–0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday through Friday, except mstockstill on PROD1PC66 with NOTICES SUMMARY: VerDate Aug<31>2005 21:55 Oct 17, 2007 Jkt 214001 Federal holidays. The telephone number is 202–366–9329. (3) Fax to: Docket Management Facility: 202–493–2251. The Docket Management Facility maintains the public docket for this notice. Comments and material received from the public, as well as documents mentioned in this notice as being available in the docket, will become part of this docket and will be available for inspection or copying at room W12–140 on the West Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at https:// www.regulations.gov. A copy of the complete ICR is available through this docket on the Internet at https://www.regulations.gov. Additionally, copies are available from Commandant (CG–611), U.S. Coast Guard Headquarters, (Attn: Mr. Arthur Requina), 2100 2nd Street, SW., Washington, DC 20593–0001. The telephone number is 202–475–3523. FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of Information Management, telephone 202–475–3523, or fax 202–475–3929, for questions on these documents. Contact Ms. Renee V. Wright, Program Manager, Docket Operations, 202–366–9826, for questions on the docket. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments We encourage you to respond to this request by submitting comments and related materials. We will post all comments received, without change, to https://www.regulations.gov. They will include any personal information you provide. We have an agreement with DOT to use their Docket Management Facility. Please see the paragraph on DOT’s ‘‘Privacy Act Policy’’ below. Submitting comments: If you submit a comment, please include the docket number for this request [USCG–2007– 0007], indicate the specific section of the document to which each comment applies, providing a reason for each comment. We recommend you include your name, mailing address, and an email address or other contact information in the body of your document to ensure that you can be identified as the submitter. This also allows us to contact you in the event further information is needed or if there are questions. For example, if we cannot read your submission due to technical difficulties and you cannot be contacted, your submission may not be PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 considered. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES; but please submit them by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change the documents supporting this collection of information or even the underlying requirements in view of them. Viewing comments and documents: Go to https://www.regulations.gov to view documents mentioned in this notice as being available in the docket. Click on ‘‘Search for Dockets,’’ and enter the docket number for this notice (USCG–2007–0007) in the Docket ID box, and click enter. You may also visit the Docket Management Facility in room W12–140 on the West Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act: Anyone can search the electronic form of all comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Privacy Act Statement of DOT in the Federal Register published on April 11, 2000 (65 FR 19477), or you may visit https://DocketsInfo.dot.gov. Information Collection Request 1. Title: Unauthorized Entry into Cuban Territorial Waters. OMB Control Number: 1625–0106. Summary: This information collection is needed to enforce, comply with and facilitate application for permits under the unauthorized entry into Cuban territorial seas regulations (33 CFR part 107) promulgated under 50 U.S.C. 191 and 194, and Presidential Proclamation 6867, 61 FR 8843, 3 CFR, 1996 Comp., p. 8; Presidential Proclamation 7757 (69 FR 9515, March 1, 2004). Need: Title 33 CFR part 107 prescribes regulations governing the unauthorized entry by U.S. vessels into Cuban territorial waters and their applications for permits to enter. The collection of information from applicants is required to comply with the regulations and to facilitate the application process for persons seeking E:\FR\FM\18OCN1.SGM 18OCN1

Agencies

[Federal Register Volume 72, Number 201 (Thursday, October 18, 2007)]
[Notices]
[Pages 59099-59100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20550]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Science Board to the Food and Drug Administration; Amendment of 
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Science Board to the Food and Drug 
Administration (Science Board). This meeting was originally announced 
in the Federal Register of October 2, 2007 (72 FR 56078). The amendment 
is being made to reflect a change in the Date and Time and Procedure 
portions of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Carlos Pe[ntilde]a, Office of the 
Commissioner, Food and Drug Administration (HF-33), 5600 Fishers Lane, 
Rockville, MD, 20857, 301-827-6687, carlos.Pe[ntilde]a@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512603.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 2, 2007, 
FDA announced that a meeting of the Science Board would be held on 
October 30, 2007. On page 56078, beginning in the second column, the 
Date and Time and Procedure portions of the document are amended to 
read as follows:
    Date and Time: The meeting will be held on December 3, 2007, from 8 
a.m. to 5:30 p.m.
    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 
November 26, 2007. Oral presentations from the public will be scheduled 
between approximately 4 p.m. and 5 p.m. Those desiring to make 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

[[Page 59100]]

or before November 16, 2007. 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 November 
19, 2007.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20550 Filed 10-17-07; 8:45 am]
BILLING CODE 4160-01-S

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