9342 Federal Register / Vol. 72, No.
40 / Thursday, March 1, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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:
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,
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Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
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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
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.
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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.
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 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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
rmajette on PROD1PC67 with NOTICES
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
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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).
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Dated: February 21, 2007.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
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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]
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