NOTICES: National Institute on Deafness and Other Communication Disorders,
Published: 2008-05-30
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 the
NOTICES: National Institute on Deafness and Other Communication Disorders,
Published: 2008-05-30
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
RULES: Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device,
Published: 2008-05-30
The Food and Drug Administration (FDA) is reclassifying the
device type, tissue adhesive for the topical approximation of skin,
from class III (premarket approval) into class II (special controls).
Tissue adhesives for nontopical uses remain in class III and continue
to require premarket approval applications (PMAs). FDA is proposing
this
PROPOSED RULES: Reclassification of Full Field Digital Mammography System,
Published: 2008-05-30
The Food and Drug Administration (FDA) is proposing to
reclassify the full field digital mammography (FFDM) system from class
III (premarket approval) to class II (special controls). The device
type is intended to produce full field digital xray images of the
breast. Elsewhere in this issue of the Federal Register, FDA is
announcing the
NOTICES: Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device,
Published: 2008-05-30
The Food and Drug Administration (FDA) is issuing for public
comment the recommendation of the Circulatory System Devices Panel (the
Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty
(PTCA) catheters, other than cutting/scoring PTCA catheters, from class
III (premarket approval) to class II (special controls). The Panel made
this
NOTICES: Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability,
Published: 2008-05-30
The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Full Field Digital Mammography System.'' This draft
guidance document describes a means by which the full field digital
mammography (FFDM) system may comply with the requirement of special
controls for
NOTICES: Board of Scientific Counselors, National Center for Health Marketing, (BSC, NCHM), Update,
Published: 2008-05-30
Correction: This notice was published in the Federal Register on
May 22, 2008, Volume 73, Number 100, page 29759. The Committee will now convene as follows:
June 5, 2008
10 a.m.12 p.m.: CDC, Auditorium A, Building 19, 1600 Clifton Road, NE., Atlanta, Georgia 30333.
1 p.m.5 p.m.: CDC, Room 247248, Building 19, 1600 Clifton Road,
NE.,
NOTICES: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters,
Published: 2008-05-30
The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance for industry and FDA staff entitled
``Class II Special Controls Guidance Document for Certain Percutaneous
Transluminal Coronary Angioplasty (PTCA) Catheters.'' The draft
guidance was developed as the special controls to support the
reclassification of PTCA
NOTICES: Tissue Adhesive for the Topical Approximation of Skin; Availability,
Published: 2008-05-30
The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Tissue Adhesive for the Topical Approximation of
Skin.'' This guidance document describes a means by which tissue
adhesive for the topical approximation of skin may comply with the
requirement of special
NOTICES: National Institute on Alcohol Abuse and Alcoholism,
Published: 2008-05-29
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
NOTICES: Vitamin Methodology Workshop; Correction,
Published: 2008-05-29
Notice is hereby given that the meeting notice which we previously
published in the Federal Register on May 20, 2008 (73 FR 2914029141)
concerning the workshop to be held on Monday, July 7th and Tuesday,
July 8th, 2008 at the Marriott Gaithersburg Washingtonian Center Hotel
in Gaithersburg, Maryland 20878, contained an error. The contact email
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-05-29
In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Heart, Lung, and
Blood Institute (NHLBI), the National Institutes of Health (NIH), will
publish periodic summaries of proposed projects to the Office of
Management
NOTICES: Government-Owned Inventions,
Published: 2008-05-29
The inventions listed below are owned by an agency of the U.S. [[Page 30953]]
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federallyfunded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
NOTICES: Center for Scientific Review,
Published: 2008-05-29
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, June 26, 2008, 1 p.m. to June
26, 2008, 3 p.m., National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 which was published in the Federal Register on May 16, 2008, 73 FR 2848928490.
The meeting will be held June 24,
NOTICES: Center for Scientific Review,
Published: 2008-05-29
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, June 23, 2008, 8 a.m. to June
24, 2008, 5 p.m., Sir Francis Drake Hotel, 450 Powell Street, San
Francisco, CA 94102 which was published in the Federal Register on May 16, 2008, 73 FR 2848928490.
The meeting will be held one day only
NOTICES: Center for Scientific Review,
Published: 2008-05-29
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, June 17, 2008, 1 p.m. to June
17, 2008, 3 p.m., National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 which was published in the Federal Register on May 15, 2008, 73 FR 2812128122.
The meeting will be held June 20,
NOTICES: Center for Scientific Review,
Published: 2008-05-29
Notice is hereby given of the cancellation of the Neurotechnology
Study Section, June 3, 2008, 8 a.m. to June 4, 2008, 5 p.m., Grand Hyatt, 345 Stockton Street, San Francisco, CA
[[Page 30955]]
94108 which was published in the Federal Register on May 15, 2008, 73 FR 2812128122.
The meeting was cancelled due to a lack of quorum.
Dated:
NOTICES: Center for Scientific Review,
Published: 2008-05-29
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, June 2, 2008, 8 a.m. to June
2, 2008, 11:30 p.m., National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD, 20892 which was published in the Federal Register on May 15, 2008, 73 FR 2812128122.
The meeting title has been
NOTICES: Subcommittee for Dose Reconstruction Reviews, Advisory Board on Radiation and Worker Health,
Published: 2008-05-29
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92463), the Centers for Disease Control and
Prevention, announces the following meeting for the aforementioned subcommittee:
Time and Date: 9 a.m.5 p.m., June 10, 2008.
Place: Cincinnati Airport Marriott, 2395 Progress Drive, Hebron,
Kentucky 41018.
NOTICES: Center for Scientific Review,
Published: 2008-05-29
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, June 24, 2008, 1 p.m. to June
24, 2008, 3 p.m., National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD, 20892 which was published in the Federal Register on May 16, 2008, 73 FR 2848928490.
The meeting will be held June
PROPOSED RULES: Content and Format of Labeling for Human Prescription Drug and Biological Products,
Published: 2008-05-29
The Food and Drug Administration (FDA) is proposing to amend
its regulations concerning the format and content of the ``Pregnancy'',
``Labor and delivery'', and ``Nursing mothers'' subsections of the
``Use in Specific Populations'' section of the labeling for human
prescription drug and biological products. The agency is proposing to
require that
NOTICES: National Center on Minority Health and Health Disparities,
Published: 2008-05-29
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
NOTICES: LUCENTIS,
Published: 2008-05-29
The Food and Drug Administration (FDA) has determined the
regulatory review period for LUCENTIS and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim