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Diversity & Cultural Competency
Visit the Diversity & Cultural Competency on the ONS website to view Diversity Champions and Multicultural Toolkits.




January 28, 2012




Transcultural Nursing Issues

On this SIGs Virtual Community page, you will find information pertaining to the Transcultural Nursing Issues SIG. Here, you can view myriad resources, download and complete pertinent documents, join in our discussions and much more. Welcome to our SIG online.

Resources
In the recent SIG survey, one of the areas that respondents identified as needing improvement is the sharing of resources.

Group that attended SIG meeting at Congress
in center of picture is Coordinator Donna Paul



REQUEST FOR NOMINATIONS FOR MEMBERS FOR THE MEDICARE EVIDENCE DEVELOPMENT & COVERAGE ADVISORY COMMITTEE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services [CMS-3254-N] Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

SUMMARY: This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for "reasonable and necessary" determinations under Medicare. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. CMS-3254-N 2

DATES: Nominations will be considered if postmarked by Monday, January 30, 2012 and mailed to the address specified in the ADDRESSES section of this notice.

ADDRESSES: You may mail nominations for membership to the following address: Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Attention: Maria Ellis, 7500 Security Boulevard, Mail Stop: South Building 3-02-01, Baltimore, MD 21244.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for the MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 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

The Secretary signed the initial charter for the Medicare Coverage Advisory Committee (MCAC) on November 24, 1998. A notice in the Federal Register (63 FR 68780) announcing establishment of the MCAC was published on December 14, 1998. The MCAC name was updated to more accurately reflect the purpose of the committee and on January 26, 2007, the Secretary published a notice in the Federal Register (72 FR 3853), announcing that the Committee's name changed to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The charter for the committee was renewed by the Secretary on November 24, 2010. The current charter is effective for 2 years. CMS-3254-N 3 The MEDCAC is governed by provisions of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formulation and use of advisory committees, and is authorized by section 222 of the Public Health Service Act as amended (42 U.S.C. 217A). The MEDCAC consists of a pool of 100 appointed members including: 94 voting members of whom 6 are designated patient advocates, and 6 nonvoting representatives of industry interests. Members generally are recognized authorities in clinical medicine including subspecialties, administrative medicine, public health, biological and physical sciences, epidemiology and biostatistics, clinical trial design, health care data management and analysis, patient advocacy, health care economics, medical ethics, or other relevant professions. The MEDCAC works from an agenda provided by the Designated Federal Official. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. The MEDCAC may also advise CMS as part of Medicare's "coverage with evidence development" initiative.

II. Provisions of the Notice

As of June 2012, there will be 30 membership terms expiring. Of the 30 memberships expiring, 1 is a nonvoting industry representative, 4 are voting patient advocates and the remaining 25 membership openings are for the general MEDCAC voting membership. CMS-3254-N 4 Accordingly, we are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore, we encourage nominations of qualified candidates from these groups. All nominations must be accompanied by curricula vitae. Nomination packages must be sent to Maria Ellis at the address listed in the ADDRESSES section of this notice. Nominees for voting membership must also have expertise and experience in one or more of the following fields:

• Clinical medicine including subspecialties

• Administrative medicine

• Public health

• Biological and physical sciences

• Epidemiology and biostatistics

• Clinical trial design

• Health care data management and analysis

• Patient advocacy

• Health care economics

• Medical ethics

• Other relevant professions

We are looking for experts in a number of fields. Our most critical needs are for experts in hematology; genomics; Bayesian statistics; clinical epidemiology; clinical trial CMS-3254-N 5 methodology; knee, hip, and other joint replacement surgery; ophthalmology; psychopharmacology; rheumatology; screening and diagnostic testing analysis; and vascular surgery. We also need experts in biostatistics in clinical settings, cardiovascular epidemiology, dementia, endocrinology, geriatrics, gynecology, minority health, observational research design, stroke epidemiology, and women's health. The nomination letter must include a statement that the nominee is willing to serve as a member of the MEDCAC and appears to have no conflict of interest that would preclude membership. We are requesting that all curricula vitae include the following:

• Date of birth

• Place of birth

• Social security number

• Title and current position

• Professional affiliation

• Home and business address

• Telephone and fax numbers

• E-mail address

• List of areas of expertise

In the nomination letter, we are requesting that the nominee specify whether they are applying for a voting patient advocate position, for another voting position, or as a nonvoting industry representative. Potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts in order to permit evaluation of possible sources of conflict of interest. CMS-3254-N 6 Members are invited to serve for overlapping 2-year terms. A member may serve after the expiration of the member's term until a successor is named. Any interested person may nominate one or more qualified persons. Self-nominations are also accepted. The current Secretary's Charter for the MEDCAC is available on the CMS website at: http://www.cms.hhs.gov/FACA/Downloads/medcaccharter.pdf, or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR

FURTHER INFORMATION section of this notice. CMS-3254-N

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare--Supplementary Medical Insurance Program.)

Dated: October 18, 2011

___________________________

Patrick Conway

CMS Chief Medical Officer and Director

Office of Clinical Standards and Quality

Centers for Medicare & Medicaid Services

BILLING CODE: 4120-01-P

[FR Doc. 2011-29784 Filed 11/17/2011 at 8:45 am; Publication Date: 11/18/2011]



FDA Call for Comments on Underrepresented Populations in Clinical Trials

Dear Members, Partners, and Friends,

Below you will find a message from the EDICT project regarding FDA's call for comments on its report regarding populations that are underrepresented in clinical trials.  This is a critically important issue.  Attached you will find the Federal Register notice regarding the call for comments.

C-Change has been an active participant in the EDICT project.  We encourage each of you review the report and comment to FDA accordingly.

Best wishes,


Tom Kean, MPH
Executive Director

FDA Call for Comments on Underrepresented Populations in Clinical Trials



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