The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar, 9342-9343 [E7-3619]

Download as PDF 9342 Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): NIOSH Occupational Safety and Health Project Grants, Program Announcement Number (PAR) 06–484 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: rmajette on PROD1PC67 with NOTICES Time and Date: 8:30 a.m.–5:30 p.m., March 15, 2007 (Closed). Place: Residence Inn, 1456 Duke Street, Alexandria, VA 22314, telephone 703–548– 5474. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The SEP meeting will include the review, discussion, and evaluation of applications received in response to ‘‘NIOSH Occupational Safety and Health Project Grants,’’ PAR 06–484. The applications being reviewed include information of a confidential nature, including personal information concerning individuals associated with the applications. This Federal Register Notice is being published on less than 15 calendar days notice to the public (41 CFR 102–3.150(b)), for the following reason: The cancellation of a preparatory meeting scheduled for January 16th due to inclement weather caused the late publication of this notice. Convening the preparatory meeting was necessary before this meeting could be scheduled. The preparatory meeting occurred on February 20–21, 2007, which enabled the program to finalize plans for this meeting. For Further Information Contact:Charles Rafferty, Ph.D., Designated Federal Officer, 1600 Clifton Road NE, Atlanta, GA 30333, telephone 404–498–2582. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: February 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7–3653 Filed 2–28–07; 8:45 am] BILLING CODE 4163–18–P VerDate Aug<31>2005 15:01 Feb 28, 2007 Jkt 211001 The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public seminar. SUMMARY: The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed’s Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device regulations. These 2-day seminars, which are designed to address the training needs of start up and small device manufacturers and their suppliers, will include both industry and FDA perspectives and a question and answer period. Dates: The seminars are planned for the following dates: 1. March 15 and 16, 2007, in Irvine, CA 92614. Details about dates are posted on AdvaMed’s Web site at: www.advamed.org/irvine.1 2. May 22 and 23, 2007, in Lakewood, CO 80228. Details about dates are posted on AdvaMed’s Web site at: www.advamed.org/denver. 3. June 6 and 7, 2007, in Pittsburgh, PA, Details about dates are posted on AdvaMed’s Web site at: www.advamed.org/pittsburgh. Locations: The seminars are planned for the following locations: 1. March 15 and 16, 2007, Crown Plaza Hotel, 17941 Von Karman, Irvine, CA 92614. Details about location sites are posted on AdvaMed’s Web site at: www.advamed.org/irvine. 2. May 22 and 23, 2007, Sheraton Denver West, 360 Union Blvd., Lakewood, CO 80228. Details about location sites are posted on AdvaMed’s Web site at: www.advamed.org/denver. 3. June 6 and 7, 2007, Hilton Pittsburgh, 600 Commonwealth Pl., Pittsburgh, PA 15222, www.HiltonPittsburgh.com. Details about location sites are posted on AdvaMed’s Web site at: www.advamed.org/pittsburgh. Contact: For FDA: William Sutton, Division of Small Manufacturers, 1 FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 International and Consumer Assistance, Center for Devices and Radiological Health (HFZ–220), 1350 Piccard Dr., Rockville, MD 20850, 800–638–2041, ext. 125, FAX: 240–276–3151, e-mail: William.sutton@fda.hhs.gov. For AdvaMed: Dia Black, 202–434– 7231, FAX: 202–783–8750, e-mail: DBlack@AdvaMed.org. Registration: The registration fee for FDA employees is waived. Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $495 per person to AdvaMed contact Dia Black, 202–434– 7231, FAX: 202–783–8750. Payment forms accepted are major credit card (MasterCard, Visa, or American Express) or company check. If you wish to pay by check, contact Dia Black at: DBlack@AdvaMed.org. To register via the Internet, go to www.AdvaMed.org. The latest information on dates/venue sites will be posted on this Web site at: www.advamed.org/irvine, www.advamed.org/denver, and www.advamed.org/pittsburgh (FDA has verified the Web site addresses, but is not responsible for changes to the Web sites after this document publishes in the Federal Register). For more information on the meeting, or for questions on registration, contact Dia Black (see Contact). Attendees are responsible for their own accommodations. For further hotel information and driving directions, go to the registration Web site. The registration fee will be used to offset the expenses of hosting the conference, including meals (breakfasts and a lunch), refreshments, meeting rooms, and training materials. It also includes a networking reception on the evening of the first day of each seminar. Space is limited; therefore, interested parties are encouraged to register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Dia Black (see Contact) at AdvaMed at least 7 days in advance of the seminar. SUPPLEMENTARY INFORMATION: The ‘‘Essentials of FDA Medical Device Regulations: A Primer for Manufacturers and Suppliers’’ seminar helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health by educating new entrepreneurs on the essentials of FDA device regulations. FDA has made education of the medical device community a high priority to assure the quality of products reaching the marketplace and to increase the rate of voluntary industry compliance with regulations. E:\FR\FM\01MRN1.SGM 01MRN1 Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Notices The seminar helps to implement the objectives of section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan for Statutory Compliance, which includes working more closely with stakeholders and ensuring access to needed scientific and technical expertise. The seminar also furthers the goals of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121) by providing outreach activities by Government agencies directed at small businesses. The following topics, as well as others, will be discussed at the seminar: • Doing business in a regulated industry; • Organizational structure of FDA; • Overview of the quality system regulation; • Design controls; • Documents, records, and change control; • Purchasing controls and acceptance activities; • Production and process control; • Corrective and preventive actions; • Complaints, medical device reports, corrections, and recalls; • Compliance issues; • Management responsibility; • Interacting with FDA—Where do you go for assistance? • General question and answer session; • Manufacturers and suppliers—the chain regulatory responsibility; • Reimbursement of medical technology; • The AdvaMed code of ethics; and • Fraud and abuse. Dated: February 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–3619 Filed 2–28–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health rmajette on PROD1PC67 with NOTICES National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings 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/or contract proposals and the discussions could disclose confidential trade secrets or commercial property VerDate Aug<31>2005 15:01 Feb 28, 2007 Jkt 211001 such as patentable material, and personal information concerning individuals associated with the grant applications, and/or contract proposals, the disclosure of which constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, ‘‘Early Diagnosis Using Nanotechnology-Based Imaging & Sensing’’ and ‘‘Multifunctional Therapeutics ‘‘Based on Nanotechnology’’. Date: March 14, 2007. Time: 8:30 a.m. to 6 p.m. Agenda: To review and evaluate contract proposals. Place: Marriott Bethesda, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Joyce C. Pegues, PhD., Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 7149, Bethesda, MD 20892, 301/594–1286, peguesj@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Community Networks Program. Date: March 22–23, 2007. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Bratin K. Saha, PhD., Scientific Review Administrator, Program Coordination and Referral Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 8041, Bethesda, MD 20892, (301) 402–0371. sahab@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, Prevention, Control and Population Science SEP. Date: March 28, 2007. Time: 10 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6116 Executive Boulevard, Conference Room 210, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Jeannette F. Korczak, PhD., Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Room 8115, Bethesda, MD 20892, 301–496–9767. korczakj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS). PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 9343 Dated: February 21, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–923 Filed 2–28–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders, Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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 on Deafness and Other Communication Disorders Special Emphasis Panel, Blueprint K18—Neurodegeneration. Date: March 16, 2007. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). Contact Person: Christine A. Livingston, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institutes of Health/NIDCD, 6120 Executive Blvd.—MSC 7180, Bethesda, MD 20892, (301) 496–8683, livingsc@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS). Dated: February 21, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–924 Filed 2–28–07; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\01MRN1.SGM 01MRN1

Agencies

[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Notices]
[Pages 9342-9343]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3619]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


The Essentials of Food and Drug Administration Medical Device 
Regulations: A Primer for Manufacturers and Suppliers; Public Seminar

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public seminar.

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

SUMMARY: The Food and Drug Administration's (FDA's) Center for Devices 
and Radiological Health and Office of Regulatory Affairs, in 
cooperation with AdvaMed's Medical Technology Learning Institute, is 
announcing a series of three seminars on FDA medical device 
regulations.
    These 2-day seminars, which are designed to address the training 
needs of start up and small device manufacturers and their suppliers, 
will include both industry and FDA perspectives and a question and 
answer period.
    Dates: The seminars are planned for the following dates:
    1. March 15 and 16, 2007, in Irvine, CA 92614. Details about dates 
are posted on AdvaMed's Web site at: www.advamed.org/irvine.\1\
_____________________________________-

 \1\ FDA has verified the Web site addresses, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.
---------------------------------------------------------------------------

    2. May 22 and 23, 2007, in Lakewood, CO 80228. Details about dates 
are posted on AdvaMed's Web site at: www.advamed.org/denver.
    3. June 6 and 7, 2007, in Pittsburgh, PA, Details about dates are 
posted on AdvaMed's Web site at: www.advamed.org/pittsburgh.
    Locations: The seminars are planned for the following locations:
    1. March 15 and 16, 2007, Crown Plaza Hotel, 17941 Von Karman, 
Irvine, CA 92614. Details about location sites are posted on AdvaMed's 
Web site at: www.advamed.org/irvine.
    2. May 22 and 23, 2007, Sheraton Denver West, 360 Union Blvd., 
Lakewood, CO 80228. Details about location sites are posted on 
AdvaMed's Web site at: www.advamed.org/denver.
    3. June 6 and 7, 2007, Hilton Pittsburgh, 600 Commonwealth Pl., 
Pittsburgh, PA 15222, www.HiltonPittsburgh.com. Details about location 
sites are posted on AdvaMed's Web site at: www.advamed.org/pittsburgh.
    Contact: For FDA: William Sutton, Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, 
800-638-2041, ext. 125, FAX: 240-276-3151, e-mail: 
William.sutton@fda.hhs.gov.
    For AdvaMed: Dia Black, 202-434-7231, FAX: 202-783-8750, e-mail: 
DBlack@AdvaMed.org.
    Registration: The registration fee for FDA employees is waived. 
Send registration information (including name, title, firm name, 
address, telephone, and fax number) and the registration fee of $495 
per person to AdvaMed contact Dia Black, 202-434-7231, FAX: 202-783-
8750. Payment forms accepted are major credit card (MasterCard, Visa, 
or American Express) or company check. If you wish to pay by check, 
contact Dia Black at: DBlack@AdvaMed.org.
    To register via the Internet, go to www.AdvaMed.org. The latest 
information on dates/venue sites will be posted on this Web site at: 
www.advamed.org/irvine, www.advamed.org/denver, and www.advamed.org/
pittsburgh (FDA has verified the Web site addresses, but is not 
responsible for changes to the Web sites after this document publishes 
in the Federal Register).
    For more information on the meeting, or for questions on 
registration, contact Dia Black (see Contact).
    Attendees are responsible for their own accommodations. For further 
hotel information and driving directions, go to the registration Web 
site.
    The registration fee will be used to offset the expenses of hosting 
the conference, including meals (breakfasts and a lunch), refreshments, 
meeting rooms, and training materials. It also includes a networking 
reception on the evening of the first day of each seminar.
    Space is limited; therefore, interested parties are encouraged to 
register early. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Dia Black (see Contact) at AdvaMed at least 7 days in advance 
of the seminar.

SUPPLEMENTARY INFORMATION: The ``Essentials of FDA Medical Device 
Regulations: A Primer for Manufacturers and Suppliers'' seminar helps 
fulfill the Department of Health and Human Services' and FDA's 
important mission to protect the public health by educating new 
entrepreneurs on the essentials of FDA device regulations. FDA has made 
education of the medical device community a high priority to assure the 
quality of products reaching the marketplace and to increase the rate 
of voluntary industry compliance with regulations.

[[Page 9343]]

    The seminar helps to implement the objectives of section 903 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan 
for Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The seminar also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed at small 
businesses.
    The following topics, as well as others, will be discussed at the 
seminar:
     Doing business in a regulated industry;
     Organizational structure of FDA;
     Overview of the quality system regulation;
     Design controls;
     Documents, records, and change control;
     Purchasing controls and acceptance activities;
     Production and process control;
     Corrective and preventive actions;
     Complaints, medical device reports, corrections, and 
recalls;
     Compliance issues;
     Management responsibility;
     Interacting with FDA--Where do you go for assistance?
     General question and answer session;
     Manufacturers and suppliers--the chain regulatory 
responsibility;
     Reimbursement of medical technology;
     The AdvaMed code of ethics; and
     Fraud and abuse.

    Dated: February 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3619 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S
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