Risk Communication on Medical Devices: Sharing Perspectives, 53105-53106 [E6-14852]

Download as PDF Federal Register / Vol. 71, No. 174 / Friday, September 8, 2006 / Notices Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a limited field of use, exclusive license in India to practice the inventions embodied in the patent referred to below to Molecular Diagnostic Laboratory, having a place of business in Lucknow, India. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are: US 6,896,892 B2 entitled ‘‘InsecticideImpregnated Fabric and Method of Production,’’ issue date 05.24.2005. CDC Technology ID No. I–008–99. Status: Issued. Issue Date: 05.24.2005 The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. Technology: This technology provides a new insecticide-impregnated fabric and method of production for bednets. In accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i), CDC is providing public notice of its intention to grant an exclusive license. CDC will accept written comments concerning this notice for 30 days. Applications for a license filed in response to this notice will be treated as objections to the grant of the contemplated license. Only written comments and/or applications for a license which are received by CDC within thirty days of this notice will be considered. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. SUPPLEMENTARY INFORMATION: Requests for a copy of this patent, inquiries, comments, and other materials relating to the contemplated license should be directed to Suzanne Seavello Shope, J.D., Technology Licensing and Marketing Specialist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K–79, Atlanta, GA 30341, telephone: (770) 488–8613; facsimile: (770) 488–8615. sroberts on PROD1PC70 with NOTICES ADDRESSES: Dated: August 31, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E6–14871 Filed 9–7–06; 8:45 am] BILLING CODE 4163–18–P VerDate Aug<31>2005 19:38 Sep 07, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Prospective Grant of Exclusive License: Diagnostics of Fungal Infections Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. ACTION: Notice. AGENCY: SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, coexclusive license to practice the inventions embodied in the patent and patent applications referred to below to Myconostica, Inc. (Myconostica) having a place of business in Manchester, United Kingdom. CDC intends to grant no more than three licenses to these inventions. The patent rights in these inventions have been assigned to the government of the United States of America. The patent and patent applications to be licensed are: Title: Nucleic Acids for Detecting Aspergillus Species and Other Filamentous Fungi. U.S. Patent Application Serial No.: 09/423,233. Filing Date: 6/27/2000. Domestic Status: 6,372,430. Issue Date: 4/16/2002. Title: Molecular Identification of Aspergillus Species. U.S. Patent Application Serial No.: 60/381,463. Filing Date: 5/17/2002. Domestic Status: Pending. Issue Date: N/A. Title: Nucleic Acids for the Identification of Fungi and Methods for Using the Same. U.S. Patent Application Serial No.: 60/325,241. Filing Date: 9/26/2001. Domestic Status: Pending. Issue Date: N/A. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. Specific DNA (oligonucleotide) probes have been developed for a wide variety of systemic disease causing fungi, including Aspergillus species and others. A probe has been developed for identification of all dimorphic fungi. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 53105 These probes can be used for the rapid identification of fungal pathogens and for the diagnosis of mycotic diseases. ADDRESSES: Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the contemplated license should be directed to Andrew Watkins, Director, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K–79, Atlanta, GA 30341, telephone: (770) 488–8610; facsimile: (770) 488–8615. Applications for a license filed in response to this notice will be treated as objections to the grant of the contemplated license. Only written comments and/or applications for a license which are received by CDC within sixty days of this notice will be considered. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. A signed Confidential Disclosure Agreement will be required to receive a copy of any pending patent application. Dated: August 31, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E6–14872 Filed 9–7–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0349] Risk Communication on Medical Devices: Sharing Perspectives AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. SUMMARY: The Food and Drug Administration (FDA), in cooperation with the Advanced Medical Technology Association (AdvaMed), is announcing a public meeting entitled ‘‘Risk Communication on Medical Devices: Sharing Perspectives.’’ This 1-day workshop is intended to bring together various creators and recipients of medical device risk/benefit information to discuss how this information is developed, disseminated, and perceived; and to explore ways in which the process might be improved. DATES AND TIMES: The public meeting will be held on September 26, 2006, from 7:30 a.m. to 5 p.m. Online registration is available until 5 p.m. on E:\FR\FM\08SEN1.SGM 08SEN1 53106 Federal Register / Vol. 71, No. 174 / Friday, September 8, 2006 / Notices September 25, 2006; however, onsite registration will be permitted if space remains (see the Registration section of this document for details). ADDRESSES: The public meeting will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852. Additional information about, and directions to, the facility are available on the Internet at https:// marriott.com/property/factsheet/wasbn. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) FOR FURTHER INFORMATION CONTACT: For FDA: Margaret Tolbert, Center for Devices and Radiological Health (HFZ–230), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276– 3240, e-mail margaret.tolbert@fda.hhs.gov. For AdvaMed: Ellen Bielinski by email at ebielinski@advamed.org, by telephone at 202–434–7223, or by FAX at 202–783–8750. SUPPLEMENTARY INFORMATION: I. Background sroberts on PROD1PC70 with NOTICES Through lectures and panel discussions, participants will learn from senior FDA and industry representatives how the Government and the medical device industry communicate expected and unexpected risks to practitioners, patients, and the general public. FDA will present the results of its recent research on risk communication. Participants will also learn from clinical practitioners, risk managers, patient advocacy organizations, and the news media how this information is received and transmitted to patients and the public. These issues will be discussed, with audience participation, by a core panel comprised of representatives from FDA, industry, and academia. Additional information regarding the public meeting agenda is available on the Internet at https://www.advamed.org/ publicdocs/ risk_communication_wkshp.shtml. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) II. Registration Those interested in attending may register online at https:// www.advamed.org/publicdocs/ risk_communication_wkshp.shtml. You may register online until September 25, VerDate Aug<31>2005 19:38 Sep 07, 2006 Jkt 208001 2006; however, onsite registration will be permitted if space remains. There is a $350 registration fee to attend the meeting. Please submit registration early in order to reserve a space, as space is limited. If you require special accommodations due to a disability, please contact Margaret Tolbert (see FOR FURTHER INFORMATION CONTACT) or the Marriott North Hotel and Conference Center at 301–822–9200, at least 7 days in advance of the meeting. Dated: August 31, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–14852 Filed 9–7–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 30-day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges File Indian Health Service, HHS. Notice. AGENCY: ACTION: SUMMARY: The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (71 FR 35921) published on June 22, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917– 0009, ‘‘Indian Health Service Medical Staff Credentials and Privileges Files.’’ Type of Information Collection Request: Extension of a currently approved information collection, 0917–0009, PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 ‘‘Indian Health Service Medical Staff Credentials and Privileges Files.’’ Form Number: None. Need and Use of Information Collection: This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. The IHS operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these service, the IHS employs (directly and under contract) several categories of health care providers including: physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physicians assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives. The IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility’s capabilities and medical staff bylaws. There are three types of IHS medical staff applicants: (1) Health care providers applying for direct employment with IHS; (2) contractors who will not seek to become IHS employees; and (3) employed IHS health care providers who seek to transfer between IHS health care facilities. National health care standards developed by the Center for Medicare and Medicaid Services (formerly the Health Care Financing Administration), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and other accrediting organizations required health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. To meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. In addition to the initial granting of medical staff membership and clinical privileges, JCAHO standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Notices]
[Pages 53105-53106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0349]


Risk Communication on Medical Devices: Sharing Perspectives

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA), in cooperation with 
the Advanced Medical Technology Association (AdvaMed), is announcing a 
public meeting entitled ``Risk Communication on Medical Devices: 
Sharing Perspectives.'' This 1-day workshop is intended to bring 
together various creators and recipients of medical device risk/benefit 
information to discuss how this information is developed, disseminated, 
and perceived; and to explore ways in which the process might be 
improved.
Dates and Times: The public meeting will be held on September 26, 2006, 
from 7:30 a.m. to 5 p.m. Online registration is available until 5 p.m. 
on

[[Page 53106]]

September 25, 2006; however, onsite registration will be permitted if 
space remains (see the Registration section of this document for 
details).

ADDRESSES: The public meeting will be held at the Marriott Bethesda 
North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, 
MD 20852. Additional information about, and directions to, the facility 
are available on the Internet at https://marriott.com/property/
factsheet/wasbn. (FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

FOR FURTHER INFORMATION CONTACT:
    For FDA: Margaret Tolbert, Center for Devices and Radiological 
Health (HFZ-230), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 240-276-3240, e-mail margaret.tolbert@fda.hhs.gov.
    For AdvaMed: Ellen Bielinski by e-mail at ebielinski@advamed.org, 
by telephone at 202-434-7223, or by FAX at 202-783-8750.

SUPPLEMENTARY INFORMATION:

I. Background

    Through lectures and panel discussions, participants will learn 
from senior FDA and industry representatives how the Government and the 
medical device industry communicate expected and unexpected risks to 
practitioners, patients, and the general public. FDA will present the 
results of its recent research on risk communication. Participants will 
also learn from clinical practitioners, risk managers, patient advocacy 
organizations, and the news media how this information is received and 
transmitted to patients and the public. These issues will be discussed, 
with audience participation, by a core panel comprised of 
representatives from FDA, industry, and academia. Additional 
information regarding the public meeting agenda is available on the 
Internet at https://www.advamed.org/publicdocs/risk_communication_
wkshp.shtml. (FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

II. Registration

    Those interested in attending may register online at https://
www.advamed.org/publicdocs/risk_communication_wkshp.shtml. You may 
register online until September 25, 2006; however, onsite registration 
will be permitted if space remains. There is a $350 registration fee to 
attend the meeting. Please submit registration early in order to 
reserve a space, as space is limited. If you require special 
accommodations due to a disability, please contact Margaret Tolbert 
(see FOR FURTHER INFORMATION CONTACT) or the Marriott North Hotel and 
Conference Center at 301-822-9200, at least 7 days in advance of the 
meeting.

    Dated: August 31, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-14852 Filed 9-7-06; 8:45 am]
BILLING CODE 4160-01-S
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