Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 21, 2010, 8980-8981 [2010-3724]

Download as PDF 8980 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Biomaterials, Delivery Systems, and Nanotechnology. Date: March 15–16, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Alexander Gubin, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6046B, MSC 7892, Bethesda, MD 20892. 301–408– 9655. gubina@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: HIV Behavior Chartered. Date: March 25, 2010. Time: 8 a.m. to 11 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Hilary D. Sigmon, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892. (301) 594– 6377. sigmonh@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Review of Member Conflict Applications. Date: March 29, 2010. Time: 11 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jose H. Guerrier, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892. 301–435– 1137. guerriej@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) sroberts on DSKD5P82C1PROD with NOTICES Dated: February 19, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–3908 Filed 2–25–10; 8:45 am] BILLING CODE 4140–01–P VerDate Nov<24>2008 18:47 Feb 25, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3223–N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—April 21, 2010 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (‘‘Committee’’) will be held on Wednesday, April 21, 2010. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services should be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding the risks, benefits, and outcomes of radiation therapy, inclusive of external beam radiotherapy (EBRT) and brachytherapy, for the treatment of localized prostate cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). DATES: Meeting date: The public meeting will be held on Wednesday, April 21, 2010 from 7:30 a.m. until 4:30 p.m., eastern daylight time (e.d.t.). Deadline for Submission of Written Comments: Written comments must be received at the address specified in the ADDRESSES section of this notice by 5 p.m., e.d.t. on March 22, 2010. Once submitted all comments are final. Deadlines for Speaker Registration and Presentation Materials: The deadline to register to be a speaker and to submit Powerpoint presentation materials and writings that will be used in support of an oral presentation, is 5 p.m., e.d.t. on Monday, March 22, 2010. Speakers may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentation materials must be received at the address specified in the ADDRESSES section of this notice. Deadline for All Other Attendees Registration: Individuals may register via e-mail at MEDCAC_Registration@cms.hhs.gov or by phone by contacting the person listed in the FOR FURTHER INFORMATION PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 CONTACT section of this notice by 5 p.m., e.d.t. on Wednesday, April 14, 2010. Deadline for Submitting a Request for Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to contact the Executive Secretary for MEDCAC as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5 p.m., e.d.t. Friday, April 2, 2010. ADDRESSES: Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. Submission of Presentations and Comments: Presentation materials and written comments that will be presented at the meeting must be submitted via email to MedCACpresentations@cms.hhs.gov or by regular mail to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, C1–09–06, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410–786–0309) or via e-mail at Maria.Ellis@cms.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background MEDCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), provides advice and recommendations to CMS regarding clinical issues. (For more information on MCAC, see the December 14, 1998 Federal Register (63 FR 68780).) This notice announces the April 21, 2010, public meeting of the Committee. During this meeting, the Committee will discuss the currently available evidence regarding the risks, benefits and outcomes of radiation therapy, inclusive of EBRT and brachytherapy, for the treatment of localized prostate cancer. Background information about this topic, including panel materials, is available at https://www.cms.hhs.gov/ coverage. We encourage the participation of appropriate organizations with expertise in radiation therapy for the treatment of localized prostate cancer. E:\FR\FM\26FEN1.SGM 26FEN1 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices II. Meeting Format This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. The Committee may limit the number and duration of oral presentations to the time available. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will be available on the following Web site prior to the meeting: https:// www.cms.hhs.gov/mcd/ index_list.asp?list_type=mcac. We require that you declare at the meeting whether you have any financial involvement with manufacturers (or their competitors) of any items or services being discussed. The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15-minute unscheduled open public session for any attendee to address issues specific to the topics under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS. III. Registration Instructions CMS’s Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver’s license), address, organization, telephone, fax number(s), and e-mail address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified the seating capacity has been reached. sroberts on DSKD5P82C1PROD with NOTICES IV. Security, Building, and Parking Guidelines This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following: • Presentation of government-issued photographic identification to the VerDate Nov<24>2008 16:39 Feb 25, 2010 Jkt 220001 Federal Protective Service or Guard Service personnel. • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: 5 U.S.C. App. 2, section 10(a). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: February 4, 2010. Barry M. Straube, Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. 2010–3724 Filed 2–25–10; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Treatment of Glaucoma by Administration of Adenosine A3 Antagonists AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application 60/010,737, entitled ‘‘Dihydropyridine, pyridine-, PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 8981 benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,’’ filed January 29, 1996 [HHS Ref. No. E–225–1995/0–US– 1], U.S. Provisional Patent Application 60/021,191, entitled ‘‘Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,’’ filed July 3, 1996 [HHS Ref. No. E–225–1995/1–US–1], PCT Application PCT/US97/01252, entitled ‘‘Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,’’ filed January 29, 1997 [HHS Ref. No. E–225–1995/2– PCT–1], U.S. Patent 6,066,642, entitled ‘‘Dihydropyridine, pyridine-, benzopyran one-, and triazoloquinazoline derivatives, their preparation and use as adenosine receptor antagonists,’’ issued May 23, 2000 [HHS Ref. No. E–225–1995/2–US– 08], Australian Patent 709190, issued December 9, 1999 [HHS Ref. No. E–225– 1995/2–AU–04], European Patent Application No. 97905627.2, filed January 29, 1997 [HHS Ref. No. E–225– 1995/2–EP–05], Hong Kong Application No. 99102653.6, filed January 29, 1997 [HHS Ref. No. E–225–1995/2–HK–06], Japanese Patent Application No. 527065/1997, filed January 29, 1997 [HHS Ref. No. E–225–1995/2–JP–07], Australian Patent 755525, issued March 27, 2003 [HHS Ref. No. E–225–1995/2– AU–02], and Canadian Patent 2244774, issued October 17, 2006 [HHS Ref. No. E–225–1995/2–CA–03], U.S. Provisional Patent Application 60/092,292, entitled ‘‘A3 Adenosine Receptor Antagonists,’’ filed July 10, 1998 [HHS Ref. No. E– 096–1998/0–US–1], PCT Application PCT/US99/15562, entitled’’A3 Adenosine Receptor Antagonists,’’ filed July 2, 1999 [HHS Ref. No. E–096–1998/ 0–PCT–2], U.S. Patent 6,376,521, entitled ‘‘A3 Adenosine Receptor Antagonists,’’ issued April 23, 2003, [HHS Ref. No. E–096–1998/0–US–04], and Canadian Patent Application No. 2336967, filed July 2, 1999 [HHS Ref. No. E–096–1998/0–CA–03], U.S. Provisional Patent Application 61/ 085,588, entitled ‘‘Truncated Methanacarba Adenosine Derivatives as A3 Antagonists,’’ filed August 1, 2008 [HHS Ref. No. E–285–2008/0–US–1], PCT Application PCT/US2009/52439, entitled ‘‘Truncated Methanacarba Adenosine Derivatives as A3 Antagonists,’’ filed July 31, 2009 [HHS Ref. No. E–285–2008/0–PCT–2], and Korean International Application No. PCT/KR2007/001131, entitled E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8980-8981]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3724]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3223-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--April 21, 2010

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

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

SUMMARY: This notice announces that a public meeting of the Medicare 
Evidence Development & Coverage Advisory Committee (MEDCAC) 
(``Committee'') will be held on Wednesday, April 21, 2010. The 
Committee generally provides advice and recommendations concerning the 
adequacy of scientific evidence needed to determine whether certain 
medical items and services should be covered under the Medicare 
statute. This meeting will focus on the currently available evidence 
regarding the risks, benefits, and outcomes of radiation therapy, 
inclusive of external beam radiotherapy (EBRT) and brachytherapy, for 
the treatment of localized prostate cancer. This meeting is open to the 
public in accordance with the Federal Advisory Committee Act (5 U.S.C. 
App. 2, section 10(a)).

DATES: Meeting date: The public meeting will be held on Wednesday, 
April 21, 2010 from 7:30 a.m. until 4:30 p.m., eastern daylight time 
(e.d.t.).
    Deadline for Submission of Written Comments: Written comments must 
be received at the address specified in the ADDRESSES section of this 
notice by 5 p.m., e.d.t. on March 22, 2010. Once submitted all comments 
are final.
    Deadlines for Speaker Registration and Presentation Materials: The 
deadline to register to be a speaker and to submit Powerpoint 
presentation materials and writings that will be used in support of an 
oral presentation, is 5 p.m., e.d.t. on Monday, March 22, 2010. 
Speakers may register by phone or via e-mail by contacting the person 
listed in the FOR FURTHER INFORMATION CONTACT section of this notice. 
Presentation materials must be received at the address specified in the 
ADDRESSES section of this notice.
    Deadline for All Other Attendees Registration: Individuals may 
register via e-mail at MEDCAC_Registration@cms.hhs.gov or by phone by 
contacting the person listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice by 5 p.m., e.d.t. on Wednesday, April 14, 2010.
    Deadline for Submitting a Request for Special Accommodations: 
Persons attending the meeting who are hearing or visually impaired, or 
have a condition that requires special assistance or accommodations, 
are asked to contact the Executive Secretary for MEDCAC as specified in 
the FOR FURTHER INFORMATION CONTACT section of this notice no later 
than 5 p.m., e.d.t. Friday, April 2, 2010.

ADDRESSES: Meeting Location: The meeting will be held in the main 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244.
    Submission of Presentations and Comments: Presentation materials 
and written comments that will be presented at the meeting must be 
submitted via e-mail to MedCACpresentations@cms.hhs.gov or by regular 
mail to the contact listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice by the date specified in the DATES section of 
this notice.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for 
MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical 
Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone 
(410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    MEDCAC, formerly known as the Medicare Coverage Advisory Committee 
(MCAC), provides advice and recommendations to CMS regarding clinical 
issues. (For more information on MCAC, see the December 14, 1998 
Federal Register (63 FR 68780).) This notice announces the April 21, 
2010, public meeting of the Committee. During this meeting, the 
Committee will discuss the currently available evidence regarding the 
risks, benefits and outcomes of radiation therapy, inclusive of EBRT 
and brachytherapy, for the treatment of localized prostate cancer. 
Background information about this topic, including panel materials, is 
available at https://www.cms.hhs.gov/coverage. We encourage the 
participation of appropriate organizations with expertise in radiation 
therapy for the treatment of localized prostate cancer.

[[Page 8981]]

II. Meeting Format

    This meeting is open to the public. The Committee will hear oral 
presentations from the public for approximately 45 minutes. The 
Committee may limit the number and duration of oral presentations to 
the time available. Your comments should focus on issues specific to 
the list of topics that we have proposed to the Committee. The list of 
research topics to be discussed at the meeting will be available on the 
following Web site prior to the meeting: https://www.cms.hhs.gov/mcd/index_list.asp?list_type=mcac. We require that you declare at the 
meeting whether you have any financial involvement with manufacturers 
(or their competitors) of any items or services being discussed.
    The Committee will deliberate openly on the topics under 
consideration. Interested persons may observe the deliberations, but 
the Committee will not hear further comments during this time except at 
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address 
issues specific to the topics under consideration. At the conclusion of 
the day, the members will vote and the Committee will make its 
recommendation(s) to CMS.

III. Registration Instructions

    CMS's Coverage and Analysis Group is coordinating meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register by contacting the person listed in 
the FOR FURTHER INFORMATION CONTACT section of this notice by the 
deadline listed in the DATES section of this notice. Please provide 
your full name (as it appears on your state-issued driver's license), 
address, organization, telephone, fax number(s), and e-mail address. 
You will receive a registration confirmation with instructions for your 
arrival at the CMS complex or you will be notified the seating capacity 
has been reached.

IV. Security, Building, and Parking Guidelines

    This meeting will be held in a Federal government building; 
therefore, Federal security measures are applicable. We recommend that 
confirmed registrants arrive reasonably early, but no earlier than 45 
minutes prior to the start of the meeting, to allow additional time to 
clear security. Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means 
of all persons entering the building. We note that all items brought 
into CMS, whether personal or for the purpose of presentation or to 
support a presentation, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set-up, safety, or timely arrival of any personal belongings 
or items used for presentation or to support a presentation.

    Note:  Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meeting. The public may not enter the building earlier than 45 
minutes prior to the convening of the meeting. All visitors must be 
escorted in areas other than the lower and first floor levels in the 
Central Building.


    Authority:  5 U.S.C. App. 2, section 10(a).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: February 4, 2010.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-3724 Filed 2-25-10; 8:45 am]
BILLING CODE 4120-01-P
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