Oncologic Drugs Advisory Committee; Notice of Meeting, 65362-65363 [2010-26651]

Download as PDF 65362 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices emcdonald on DSK2BSOYB1PROD with NOTICES Medicare conditions for participation for psychiatric hospitals. the survey as we may require (including corrective action plans). DEPARTMENT OF HEALTH AND HUMAN SERVICES III. Evaluation of Deeming Authority Request The Joint Commission submitted all the necessary materials to enable us to make a determination concerning its request for approval as a deeming organization for psychiatric hospitals. This application was determined to be complete on September 3, 2010. Under section 1865(a)(2) of the Act and § 488.8 (Federal review of accrediting organizations), our review and evaluation of the Joint Commission will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of the Joint Commission’s standards for a psychiatric hospital as compared with CMS’ psychiatric hospital conditions of participation. • The Joint Commission’s survey process to determine the following: + The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. + The comparability of the Joint Commission’s processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. + The Joint Commission’s processes and procedures for monitoring psychiatric hospitals found out of compliance with the Joint Commission’s program requirements. These monitoring procedures are used only when the Joint Commission identifies noncompliance. If noncompliance is identified through validation reviews, the State survey agency monitors corrections as specified at § 488.7(d). + The Joint Commission’s capacity to report deficiencies to the surveyed facilities and respond to the facility’s plan of correction in a timely manner. + The Joint Commission’s capacity to provide us with electronic data and reports necessary for effective validation and assessment of the organization’s survey process. + The adequacy of the Joint Commission’s staff and other resources, and its financial viability. + The Joint Commission’s capacity to adequately fund required surveys. + The Joint Commission’s policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. + The Joint Commission’s agreement to provide us with a copy of the most current accreditation survey together with any other information related to IV. Response to Public Comments and Notice Upon Completion of Evaluation Food and Drug Administration VerDate Mar<15>2010 17:43 Oct 21, 2010 Jkt 223001 Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the Federal Register announcing the result of our evaluation. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). VI. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this proposed notice. In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or Tribal governments. Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: October 14, 2010. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2010–26716 Filed 10–21–10; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 [Docket No. FDA–2010–N–0001] Oncologic Drugs 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: Oncologic 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 1, 2010, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, Bldg 31, the Great Room, White Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. 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 ‘‘White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings’’. Contact Person: Nicole Vesely, 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, 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 301–451– 2542. 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 December 1, 2010, the committee will discuss supplemental new drug applications (sNDAs) 021– 319/S–024, trade name AVODART (dutasteride) Soft Gelatin Capsules, E:\FR\FM\22OCN1.SGM 22OCN1 emcdonald on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices manufactured by SmithKline Beecham Corp. d/b/a (doing business as) GlaxoSmithKline and 020–180/S–034, trade name PROSCAR (finasteride) Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposed expansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined. 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 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 16, 2010. Oral presentations from the public will be scheduled between approximately 2:30 p.m. to 3:30 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 8, 2010. 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, VerDate Mar<15>2010 17:43 Oct 21, 2010 Jkt 223001 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 9, 2010. 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/ 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: October 13, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–26651 Filed 10–21–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Basic Behavioral and Social Science Opportunity Network (OppNet) ACTION: Notice. A two-day meeting highlighting OppNet’s activities and future goals is scheduled for Thursday, October 28, and Friday, October 29, 2010, at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington DC 20001. This is the first public meeting to promote and publicize the Basic Behavioral and Social Science Opportunity Network (OppNet) initiative. Attendance is limited to prior registration via https:// www.regonline.com/oppnet. Background: The Basic Behavioral and Social Science Opportunity Network (OppNet) is a trans-NIH initiative to expand the agency’s funding of basic behavioral and social sciences research (b-BSSR). OppNet prioritizes activities and initiatives that focus on basic mechanisms of behavior SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 65363 and social processes that are relevant to the missions and public health challenges of multiple NIH Institutes, Centers, and Offices (ICOs) and that build upon existing NIH investments without replicating them. https:// www.oppnet.nih.gov. Participating: The meeting will take place on October 28, from 9 a.m. to 4:30 p.m., and October 29, from 8:30 a.m. to 2:30 p.m., at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington DC 20001. FOR FURTHER INFORMATION CONTACT: To register, visit the registration Web site at https://regonline.com/oppnet, call William Elwood at 301–402–0116, or email elwoodwi@od.nih.gov. Dated: October 15, 2010. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2010–26709 Filed 10–21–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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 General Medical Sciences Special Emphasis Panel; Review of Minority Biomedical Research Neuro Grant Applications. Date: December 6, 2010. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency-Bethesda, 7400 Wisconsin Avenue, One Bethesda Metro Center, Bethesda, MD 20814. Contact Person: John J. Laffan, PhD, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN18J, Bethesda, MD 20892, 301–594–2773, laffanjo@mail.nih.gov. E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Notices]
[Pages 65362-65363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26651]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Oncologic Drugs 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: Oncologic 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 1, 2010, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, Bldg 31, the Great Room, White Oak 
Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002. 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 ``White Oak Conference Center Parking 
and Transportation Information for FDA Advisory Committee Meetings''.
    Contact Person: Nicole Vesely, 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, 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 301-451-2542. 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 December 1, 2010, the committee will discuss 
supplemental new drug applications (sNDAs) 021-319/S-024, trade name 
AVODART (dutasteride) Soft Gelatin Capsules,

[[Page 65363]]

manufactured by SmithKline Beecham Corp. d/b/a (doing business as) 
GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride) 
Tablets, manufactured by Merck & Co., Inc. The proposed indication 
(use) for AVODART (dutasteride) is for reduction in the risk of 
prostate cancer in men at increased risk of developing the disease. The 
population at increased risk of prostate cancer includes men with an 
elevated serum prostate-specific antigen (PSA) or men otherwise 
determined to be at increased risk based on other associated risk 
factors such as age, race, and family history. There is no proposed 
expansion of the indication for PROSCAR (finasteride); however, in 
light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated 
a statistically significant reduction in the 7-year period prevalence 
of prostate cancer with finasteride (PROSCAR) treatment, and which 
reported an imbalance in high Gleason grade prostate cancers 
(indicating more aggressive cancers) in the finasteride treatment arm 
vs. placebo, the efficacy and safety of both products for use in 
prostate cancer risk reduction will be examined.
    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 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 16, 2010. Oral presentations from the public will be scheduled 
between approximately 2:30 p.m. to 3:30 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 8, 2010. 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 9, 2010.
    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/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: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26651 Filed 10-21-10; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.