Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period, 10294-10295 [2010-4662]
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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
Medical Center. The meeting will be
held on Friday, March 19, 2010, at the
National Institutes of Health, Building
31, 31 Center Drive, Floor 6C, Room 6,
Bethesda, MD 20892, from
approximately 8:30 a.m. to 2 p.m.
This meeting is the second in a series
of public meetings with the National
Research Council to review the ongoing
supplementary risk assessment study. It
was originally scheduled to take place
on February 12, 2010, but had to be
postponed due to extreme weather
conditions on the East Coast.
Signup for public comment will begin
at approximately 8 a.m. In the event that
time does not allow for all those
interested in presenting oral comments,
anyone may file written comments
using the following address below.
An agenda and slides for the meeting
may be obtained prior to the meeting by
connecting to https://
nihblueribbonpanel-bumcneidl.od.nih.gov/. For additional
information concerning this meeting,
please contact Ms. Laurie Lewallen,
Advisory Committee Coordinator, Office
of Biotechnology Activities, Office of
Science Policy, Office of the Director,
National Institutes of Health, 6705
Rockledge Drive, Room 750, Bethesda,
MD 20892–7985; telephone 301–496–
9838; e-mail lewallenl@od.nih.gov.
Dated: March 1, 2010.
Amy P. Patterson,
Director, Office of Biotechnology Activities,
National Institutes of Health.
[FR Doc. 2010–4724 Filed 3–4–10; 8:45 am]
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for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE ON DEAFNESS
AND OTHER COMMUNICATION
DISORDERS, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIDCD.
Date: March 26, 2010.
Open: 7:30 a.m. to 8 a.m.
Agenda: Reports from institute staff.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room F1/
F2, Bethesda, MD 20892.
Closed: 8 a.m. to 4:30 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room F1/
F2, Bethesda, MD 20892.
Contact Person: Andrew J. Griffith, Ph.D.,
MD., Director, Division of Intramural
Research, National Institute on Deafness and
Other Communication Disorders, 5 Research
Court, Room 1A13, Rockville, MD 20850,
301–496–1960, griffita@nidcd.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: March 1, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2010–4767 Filed 3–4–10; 8:45 am]
erowe on DSK5CLS3C1PROD with NOTICES
National Institute on Deafness and
Other Communication Disorders;
Notice of Meeting
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIDCD.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0054]
Strengthening the Center for Devices
and Radiological Health’s 510(k)
Review Process; Public Meeting;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; extension of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is extending to
March 19, 2010, the comment period for
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the notice that appeared in the Federal
Register of Wednesday, January 27,
2010 (75 FR 4402). In the notice, FDA
requested comments on a number of
identified challenges associated with
the 510(k) process. The agency is taking
this action to allow interested persons
additional time to submit comments.
DATES: Submit written or electronic
comments and information by March
19, 2010.
ADDRESSES: Submit written comments
or information to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments or
information to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1609, Silver Spring,
MD 20993, 301–796–6313, e-mail:
james.swink@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 27,
2010 (75 FR 4402), FDA published a
notice announcing a public meeting on
February 18, 2010, and the opening of
a public docket to receive comments on
key challenges related to the premarket
notification (or 510(k)) process for the
review of medical devices. Specific
questions for comment were listed and
interested persons were invited to
submit comments by March 5, 2010. At
this time, the agency is extending the
comment period until March 19, 2010,
to continue to receive public comments.
Comments submitted to the docket will
assist in identifying actions that the
Center for Devices and Radiological
Health can consider taking to strengthen
the 510(k) process.
II. Submission of Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
All comments submitted to the public
docket are public information and may
be posted to FDA’s Web site at https://
www.fda.gov for public viewing.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. In addition,
E:\FR\FM\05MRN1.SGM
05MRN1
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
when responding to specific questions
as outlined in the Federal Register of
January 27, 2010, please identify the
question you are addressing. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–4662 Filed 3–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
erowe on DSK5CLS3C1PROD with NOTICES
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; The Early
Detection Research Network: Biomarker
Reference Laboratories.
Date: March 23, 2010.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Legacy Hotel and Meeting Center,
1775 Rockville Pike, Rockville, MD 20852.
Contact Person: Gerald G. Lovinger, PhD,
Scientific Review Administrator, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Blvd., Room 8101,
Bethesda, MD 20892–8329, 301/496–7987,
lovingeg@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Pharmacodynamic Assays.
Date: March 23, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Legacy Hotel and Meeting Center,
1775 Rockville Pike, Rockville, MD 20852.
Contact Person: Thomas M. Vollberg, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
VerDate Nov<24>2008
14:45 Mar 04, 2010
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Executive Boulevard, Room 7142, Bethesda,
MD 20892, 301–594–9582,
vollbert@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI–
CNP(U54) Review.
Date: April 7–9, 2010.
Time: 5 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington, DC/Rockville
Hotel, 1750 Rockville Pike, Rockville, MD
20852.
Contact Person: Bratin K. Saha, PhD,
Scientific Review Officer, Program
Coordination and Referral Branch, Division
of Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Boulevard,
Room 8041, Bethesda, MD 20892, (301) 402–
0371, sahab@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)
Dated: February 26, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4727 Filed 3–4–10; 8:45 am]
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10295
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sherry L. Dupere, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5136,
MSC 7843, Bethesda, MD 20892, (301) 435–
1021, duperes@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflicts: Arthritis, Connective Tissue, and
Skin.
Date: March 30, 2010.
Time: 1:30 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).
Contact Person: Jean D. Sipe, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4106,
MSC 7814, Bethesda, MD 20892, 301/435–
1743, sipej@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 1, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4726 Filed 3–4–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of
Closed Meetings
National Institutes of Health
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
Conflict: Topics in Aging, Cellular and
Developmental Biology.
Date: March 23, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 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 of
Allergy and Infectious Diseases Special
Emphasis Panel; Viral Immunity.
Date: March 31, 2010.
Time: 12:30 p.m. to 4:30 p.m.
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]]>Agencies
[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10294-10295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4662]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0054]
Strengthening the Center for Devices and Radiological Health's
510(k) Review Process; Public Meeting; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to March
19, 2010, the comment period for the notice that appeared in the
Federal Register of Wednesday, January 27, 2010 (75 FR 4402). In the
notice, FDA requested comments on a number of identified challenges
associated with the 510(k) process. The agency is taking this action to
allow interested persons additional time to submit comments.
DATES: Submit written or electronic comments and information by March
19, 2010.
ADDRESSES: Submit written comments or information to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
or information to https://www.regulations.gov. Identify comments with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1609, Silver Spring, MD 20993, 301-796-6313, e-
mail: james.swink@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 27, 2010 (75 FR 4402), FDA
published a notice announcing a public meeting on February 18, 2010,
and the opening of a public docket to receive comments on key
challenges related to the premarket notification (or 510(k)) process
for the review of medical devices. Specific questions for comment were
listed and interested persons were invited to submit comments by March
5, 2010. At this time, the agency is extending the comment period until
March 19, 2010, to continue to receive public comments. Comments
submitted to the docket will assist in identifying actions that the
Center for Devices and Radiological Health can consider taking to
strengthen the 510(k) process.
II. Submission of Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy. All
comments submitted to the public docket are public information and may
be posted to FDA's Web site at https://www.fda.gov for public viewing.
Comments are to be identified with the docket number found in brackets
in the heading of this document. In addition,
[[Page 10295]]
when responding to specific questions as outlined in the Federal
Register of January 27, 2010, please identify the question you are
addressing. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4662 Filed 3-4-10; 8:45 am]
BILLING CODE 4160-01-S
