Arthritis Advisory Committee; Notice of Meeting, 32031-32032 [E8-12646]

Download as PDF yshivers on PROD1PC62 with NOTICES Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Notices 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: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. 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 July 22 and 23, 2008, from 8:30 a.m. to 5 p.m. Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Diem-Kieu Ngo, 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: Diem.Ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in the Washington, DC area), code 3014512539. 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: On July 22, 2008, the committee will do the following: (1) Receive presentations from the Office of Pharmaceutical Science (OPS) and discuss current thinking on issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products, and (2) receive an update from OPS, discuss, and make comments on current strategies and directions for the testing of lead in pharmaceutical products. On July 23, 2008, the committee will do the following: (1) Receive and discuss presentations from the Office of Generic Drugs (OGD) on the bioequivalence methods for locally acting drugs that treat gastrointestinal (GI) conditions, (2) receive and discuss presentations from OGD on the use of inhaled corticosteroid dose-response as a means to establish bioequivalence of inhalation drug products, and (3) receive and discuss presentations from OPS on the drug classification of orally VerDate Aug<31>2005 14:51 Jun 04, 2008 Jkt 214001 disintegrating tablets (ODT) as a separate dosage form, and the need for subsequent guidance on expectations and recommendations that would be required for applications proposing the dosage form. 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 2008 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 July 8, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. each day. 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 June 30, 2008. 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 July 1, 2008. 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 Diem-Kieu Ngo 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 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 32031 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 27, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–12647 Filed 6–4–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis 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 Committee: Arthritis 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 July 29, 2008, from 8:30 a.m. to 3:30 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301–589–5200. Contact Person: Nicole Vesely, 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, 301–827–6793, FAX: 301–827–6776, e-mail: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512532. 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 biologics license application (BLA) 125276, ACTEMRA (tocilizumab), E:\FR\FM\05JNN1.SGM 05JNN1 yshivers on PROD1PC62 with NOTICES 32032 Federal Register / Vol. 73, No. 109 / Thursday, June 5, 2008 / Notices Hoffman-La Roche, Inc., for the proposed treatment of adult patients with moderately to severely active rheumatoid arthritis. 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 2008 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 July 15, 2008. Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:45 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 July 7, 2008. 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 July 8, 2008. 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 Nicole Vesely 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. VerDate Aug<31>2005 14:51 Jun 04, 2008 Jkt 214001 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 27, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–12646 Filed 6–4–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 60-Day Proposed Information Collection: Behavioral Health Preventive Care Assessment Focus Group Guide; Correction ACTION: Notice; correction. SUMMARY: The Indian Health Service published a document in the Federal Register (FR) on April 29, 2008. The document contained one error. FOR FURTHER INFORMATION CONTACT: Christina Rouleau, Office of Management Services, Indian Health Service, 801 Thompson Avenue, Suite 450, Rockville, MD 20852, Telephone (301) 443–5938. (This is not a toll-free number.) Correction In the Federal Register of April 29, 2008, in FR Doc. E8–9258, on page 23254, in the second column, second paragraph, under SUMMARY, correct Domestic/Intimate Partner Violence screening in women ages 14–15 to read: Domestic/Intimate Partner Violence screening in women ages 15–40. Dated: May 29, 2008. Robert G. McSwain, Director, Indian Health Service. [FR Doc. E8–12509 Filed 6–4–08; 8:45 am] BILLING CODE 4165–16–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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., PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 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: Allergy, Immunology, and Transplantation Research Committee; Allergy, Immunology and Transportation Research Committee (AITRC). Date: June 24, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: DoubleTree Hotel, 1515 Rhode Island Ave., NW., Director’s Room 2nd Floor, Washington, DC 20005. Contact Person: Katrin Eichelberg, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda MD 20892, (301) 496– 0818, keichelberg@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: May 27, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–12282 Filed 6–4–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, June 30, 2008, 8 a.m. to July 1, 2008, 5 p.m., Doubletree Hotel, 1515 Rhode Island Avenue, NW., Washington, DC 20005, which was published in the Federal Register on May 15, 2008, 73 FR 28122– 28123. The meeting will be held one day only, June 30, 2008. The meeting time and location remain the same. The meeting is closed to the public. Dated: May 27, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–12275 Filed 6–4–08; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[Federal Register Volume 73, Number 109 (Thursday, June 5, 2008)]
[Notices]
[Pages 32031-32032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12646]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Arthritis 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 Committee: Arthritis 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 July 29, 2008, from 8:30 
a.m. to 3:30 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Nicole Vesely, 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, 
301-827-6793, FAX: 301-827-6776, e-mail: nicole.vesely@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512532. 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 biologics license application 
(BLA) 125276, ACTEMRA (tocilizumab),

[[Page 32032]]

Hoffman-La Roche, Inc., for the proposed treatment of adult patients 
with moderately to severely active rheumatoid arthritis.
    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 2008 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 July 
15, 2008. Oral presentations from the public will be scheduled between 
approximately 12:45 p.m. and 1:45 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 July 7, 2008. 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 July 8, 
2008.
    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 Nicole Vesely 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).

    Dated: May 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-12646 Filed 6-4-08; 8:45 am]
BILLING CODE 4160-01-S

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