National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR); Notice of National Conversation on Public Health and Chemical Exposures Leadership Council Meeting, 59727-59728 [2010-24260]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Haja
Sittana El Mubarak, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5519, Silver Spring,
MD 20993–0002, 301–796–6193.
SUPPLEMENTARY INFORMATION:
srobinson on DSKHWCL6B1PROD with NOTICES
I. Background
This draft guidance document
provides recommendations on the types
of information and data that FDA
believes needs to be included in a
premarket notification 510(k)
submission for HSV types 1 and 2
serological assays. HSV serological
assays are devices that consist of
antigens and antisera used in various
serological tests to identify antibodies to
herpes simplex virus in serum.
Additionally, some of the assays consist
of herpes simplex virus antisera
conjugated with a fluorescent dye
(immunofluorescent assays) used to
identify herpes simplex virus directly
from clinical specimens or tissue
culture isolates derived from clinical
specimens. The identification aids in
the diagnosis of diseases caused by
herpes simplex viruses and provides
epidemiological information on these
diseases. Herpes simplex viral
infections range from common and mild
lesions of the skin and mucous
membranes to a severe form of
encephalitis (inflammation of the brain).
Neonatal herpes virus infections range
from a mild infection to a severe
generalized disease with a fatal
outcome. We have revised the existing
guidance by rewriting the method
comparison section and the sample
selection inclusion and exclusion
criteria section. The revisions defined
and differentiated the required studies
and the study populations for the
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
assessment of the safety and
effectiveness of the different types of
HSV 1 and HSV 2 serological assays.
Additionally, we made several
corrections and clarifications
throughout the document to ensure
accuracy, consistency, and ease of
reading. Elsewhere in this issue of the
Federal Register, FDA is proposing to
designate this guidance as the class II
special control for HSV types 1 and 2
serological assays. If this classification
rule is finalized, FDA intends that this
guidance document will serve as the
special control for this device.
Following the effective date of any
final classification rule based on this
proposal, any firm submitting a
premarket notification (510(k)) for HSV
types 1 and 2 serological assays will
need to address the issues covered in
the special controls guidance document.
However, the firm need only show that
its device meets the recommendations
of the guidance document or in some
other way provides equivalent
assurances of safety and effectiveness.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on HSV types 1 and 2 serological assays.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Class II Special
Controls Guidance Document: Herpes
Simplex Virus Types 1 and 2
Serological Assays,’’ you may either
send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1713 to identify the guidance
you are requesting. A search capability
for all CDRH guidance documents is
available at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
59727
and guidance documents. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; and the collections
of information in 21 CFR part 801 and
21 CFR 809.10 have been approved
under OMB control number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–23640 Filed 9–27–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (NCEH/ATSDR);
Notice of National Conversation on
Public Health and Chemical Exposures
Leadership Council Meeting
Time and Date: 9 a.m.—5 p.m. EDT,
Tuesday, October 5, 2010.
Location: Omni Shoreham Hotel, 2500
Calvert Street NW., Washington, DC
20008.
Status: Open to the public, on a first
come, first served basis, limited by the
space available. An opportunity for the
public to listen to the meeting by phone
will be available. For information on
observing the meeting in person or by
phone, see ‘‘contact for additional
information’’ below.
Purpose: This is the sixth meeting of
the National Conversation on Public
E:\FR\FM\28SEN1.SGM
28SEN1
59728
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
Health and Chemical Exposures
Leadership Council, which is convened
by RESOLVE, a non-profit independent
facilitator. The National Conversation
on Public Health and Chemical
Exposures is a collaborative initiative
supported by NCEH/ATSDR and
through which many organizations and
individuals are helping develop an
action agenda for strengthening the
nation’s approach to protecting the
public’s health from harmful chemical
exposures. The Leadership Council
provides overall guidance to the
National Conversation project and is
responsible for issuing the final action
agenda. For additional information on
the National Conversation on Public
Health and Chemical Exposures, visit
this Web site: https://www.atsdr.cdc.gov/
nationalconversation/.
Meeting Agenda: The purpose of the
meeting is to discuss key themes and
recommendations to feature in the draft
action agenda, drawing on draft work
group reports and the results of various
stakeholder and public engagement
activities.
Contact for additional information: If
you would like to receive additional
information on attending this meeting in
person or listening by telephone, please
contact: nationalconversation@cdc.gov
or Ben Gerhardstein at 770–488–3646.
Dated: September 21, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–24260 Filed 9–27–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
srobinson on DSKHWCL6B1PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
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: Center for Scientific
Review Special Emphasis Panel; Member
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
Conflict: Neurodevices, Neuroimaging, and
Bioengineering.
Date: October 20, 2010.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Vilen A. Movsesyan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M,
MSC 7806, Bethesda, MD 20892, 301–402–
7278, movsesyanv@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Electromagnetic Devices.
Date: October 26, 2010.
Time: 12 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Antonio Sastre, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5215,
MSC 7412, Bethesda, MD 20892, 301–435–
2592, sastrea@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: AIDS Predoctoral and
Postdoctoral.
Date: October 27–28, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Shiv A. Prasad, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Dermatology, Rheumatology and
Inflammation.
Date: November 1, 2010.
Time: 11:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Aftab A. Ansari, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4108,
MSC 7814, Bethesda, MD 20892, 301–594–
6376, ansaria@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Stem Cells
in Cancer.
Date: November 1, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Contact Person: Nywana Sizemore, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6204,
MSC 7804, Bethesda, MD 20892, 301–435–
1718, sizemoren@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Tooth
Development and Mineralization.
Date: November 3, 2010.
Time: 3 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Priscilla B. Chen, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4104,
MSC 7814, Bethesda, MD 20892, (301) 435–
1787, chenp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–08–
147: Quick Trials on Imaging and imageGuided Intervention.
Date: November 4, 2010.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: John Firrell, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
MSC 7854, Bethesda, MD 20892, 301–435–
2598, firrellj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel.
Fellowships: Neurodevelopment, Synaptic
Plasticity and Neurodegeneration.
Date: November 11–12, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin San Diego, 400 West
Broadway, San Diego, CA 92101.
Contact Person: Vilen A. Movsesyan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M,
MSC 7806, Bethesda, MD 20892, 301–402–
7278, movsesyanv@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Digestive Sciences.
Date: November 15–16, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Bonnie L. Burgess-Beusse,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, 301–435–
1783, beusseb@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Diet and Physical Activity Methodologies.
Date: November 16–17, 2010.
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59727-59728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24260]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Environmental Health/Agency for Toxic
Substances and Disease Registry (NCEH/ATSDR); Notice of National
Conversation on Public Health and Chemical Exposures Leadership Council
Meeting
Time and Date: 9 a.m.--5 p.m. EDT, Tuesday, October 5, 2010.
Location: Omni Shoreham Hotel, 2500 Calvert Street NW., Washington,
DC 20008.
Status: Open to the public, on a first come, first served basis,
limited by the space available. An opportunity for the public to listen
to the meeting by phone will be available. For information on observing
the meeting in person or by phone, see ``contact for additional
information'' below.
Purpose: This is the sixth meeting of the National Conversation on
Public
[[Page 59728]]
Health and Chemical Exposures Leadership Council, which is convened by
RESOLVE, a non-profit independent facilitator. The National
Conversation on Public Health and Chemical Exposures is a collaborative
initiative supported by NCEH/ATSDR and through which many organizations
and individuals are helping develop an action agenda for strengthening
the nation's approach to protecting the public's health from harmful
chemical exposures. The Leadership Council provides overall guidance to
the National Conversation project and is responsible for issuing the
final action agenda. For additional information on the National
Conversation on Public Health and Chemical Exposures, visit this Web
site: https://www.atsdr.cdc.gov/nationalconversation/.
Meeting Agenda: The purpose of the meeting is to discuss key themes
and recommendations to feature in the draft action agenda, drawing on
draft work group reports and the results of various stakeholder and
public engagement activities.
Contact for additional information: If you would like to receive
additional information on attending this meeting in person or listening
by telephone, please contact: nationalconversation@cdc.gov or Ben
Gerhardstein at 770-488-3646.
Dated: September 21, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-24260 Filed 9-27-10; 8:45 am]
BILLING CODE 4163-18-P
