Medicare Program; Meeting of the Medicare Evidence Development & Coverage Advisory Committee-February 25, 2009, 77717-77718 [E8-30162]

Download as PDF Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices Dated: December 4, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E8–30001 Filed 12–18–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3209–N] Medicare Program; Meeting of the Medicare Evidence Development & Coverage Advisory Committee— February 25, 2009 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, February 25, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the requirements for evidence to determine if diagnostic use of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will also discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. 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: This meeting will be held on Wednesday, February 25, 2009 from 7:30 a.m. until 4:30 p.m., eastern standard time (e.s.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.s.t on January 29, 2009. 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.s.t. on January 29, 2009. Speakers may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT VerDate Aug<31>2005 17:29 Dec 18, 2008 Jkt 217001 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 by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., e.s.t. on Wednesday, February 18, 2009. 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 as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5 p.m., e.s.t. Friday, February 18, 2009. ADDRESSES: Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Blvd, 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 at 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 February 25, 2009, public meeting of the Committee. During this meeting, the Committee will discuss the requirements for evidence to determine if diagnostic uses of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. Background information about this topic, including panel materials, are PO 00000 Frm 00127 Fmt 4703 Sfmt 4703 77717 available at http://ww.cms.hhs.gov/ coverage. We encourage the participation of appropriate organizations with expertise in the evidence regarding this use of genomic testing. 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: http:// 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’ 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 E:\FR\FM\19DEN1.SGM 19DEN1 77718 Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices 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 brought 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 30 to 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: December 11, 2008. Barry M. Straube, Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. E8–30162 Filed 12–18–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0635] Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly ‘‘Emergency Medical Device Shortages Program Survey’’) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Aug<31>2005 22:25 Dec 18, 2008 Jkt 217001 SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Emergency Shortages Data Collection System. DATES: Submit written or electronic comments on the collection of information by February 17, 2009. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Emergency Shortages Data Collection System (formerly ‘‘Emergency Medical Device Shortages Program Survey’’)— Federal Food, Drug, and Cosmetic Act, Section 903(d)(2) (OMB Control Number 0910–0491)—Extension Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner of FDA is authorized to implement general powers (including conducting research) to carry out effectively the mission of FDA. Subsequent to the events of September 11, 2001, and as part of broader counter-terrorism and emergency preparedness activities, FDA’s Center for Devices and Radiological Health (CDRH) began developing operational plans and interventions that would enable CDRH to anticipate and respond to medical device shortages that might arise in the context of federally-declared disasters/ emergencies or regulatory actions. In particular, CDRH identified the need to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand, and/or would be vulnerable to shortages in specific disaster/emergency situations, or following specific regulatory actions. Such data could support prospective risk assessment, help inform risk mitigation strategies, and support realtime decisionmaking by the Department of Health and Human Services during actual emergencies or emergency preparedness exercises. ‘‘The Emergency Medical Device Shortages Program Survey’’ was developed in 2002 to support the acquisition of such data from medical device manufacturers. In 2004, CDRH changed the process for the data collection, and the electronic database in which the data were stored and was formally renamed the ‘‘Emergency Shortages Data Collection System’’ (ESDCS). Recognizing that some of the data collected may be commercially confidential, access to the ESDCS is restricted to members of the FDA Emergency Shortage Team (EST) and senior management with a need-to- E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77717-77718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3209-N]


Medicare Program; Meeting of the Medicare Evidence Development & 
Coverage Advisory Committee--February 25, 2009

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, February 25, 2009. The 
Committee generally provides advice and recommendations concerning the 
adequacy of scientific evidence needed to determine whether certain 
medical items and services can be covered under the Medicare statute. 
This meeting will focus on the requirements for evidence to determine 
if diagnostic use of genomic testing in beneficiaries with signs or 
symptoms of disease improves health outcomes in Medicare beneficiaries. 
The meeting will also discuss the various kinds of evidence that are 
useful to support requests for Medicare coverage in this field. 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: This meeting will be held on Wednesday, February 
25, 2009 from 7:30 a.m. until 4:30 p.m., eastern standard time (e.s.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.s.t on January 29, 2009. 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.s.t. on January 29, 2009. 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 by phone or via e-mail by contacting the person listed in the 
FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., 
e.s.t. on Wednesday, February 18, 2009.
    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 as specified in the FOR 
FURTHER INFORMATION CONTACT section of this notice no later than 5 
p.m., e.s.t. Friday, February 18, 2009.

ADDRESSES: Meeting Location: The meeting will be held in the main 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Blvd, 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 
at 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 February 25, 
2009, public meeting of the Committee. During this meeting, the 
Committee will discuss the requirements for evidence to determine if 
diagnostic uses of genomic testing in beneficiaries with signs or 
symptoms of disease improves health outcomes in Medicare beneficiaries. 
Background information about this topic, including panel materials, are 
available at http://ww.cms.hhs.gov/coverage. We encourage the 
participation of appropriate organizations with expertise in the 
evidence regarding this use of genomic testing.

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: http://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' 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

[[Page 77718]]

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 brought 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 30 to 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: December 11, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-30162 Filed 12-18-08; 8:45 am]
BILLING CODE 4120-01-P