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1801. National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

NOTICES: National Institute on Deafness and Other Communication Disorders,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1802. National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

NOTICES: National Institute on Deafness and Other Communication Disorders,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1803. General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device

RULES: Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1804. Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System

PROPOSED RULES: Reclassification of Full Field Digital Mammography System,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1805. Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters

NOTICES: Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1806. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full

NOTICES: Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1807. Board of Scientific Counselors, National Center for Health Marketing, (BSC, NCHM)

NOTICES: Board of Scientific Counselors, National Center for Health Marketing, (BSC, NCHM), Update,

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.,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

1808. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for

NOTICES: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1809. Agency Information Collection Activities: Proposed Collection; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

1810. Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue

NOTICES: Tissue Adhesive for the Topical Approximation of Skin; Availability,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1811. Agency Information Collection Activities: Submission for OMB Review; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

1812. National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

NOTICES: National Institute on Alcohol Abuse and Alcoholism,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1813. Office of Dietary Supplements (ODS) Methods and Reference Materials Program--Vitamin Methodology Workshop; Correction

NOTICES: Vitamin Methodology Workshop; Correction,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1814. Proposed Collection; Comment Request; The Prevalence and Incidence of HIV Molecular Variants and Their Correlation

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1815. Government-Owned Inventions; Availability for Licensing

NOTICES: Government-Owned Inventions,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1816. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

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,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1817. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1818. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

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,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1819. Center for Scientific Review; Cancellation of Meeting

NOTICES: Center for Scientific Review,

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:

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1820. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1821. Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH), National

NOTICES: Subcommittee for Dose Reconstruction Reviews, Advisory Board on Radiation and Worker Health,

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

1822. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1823. Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and

PROPOSED RULES: Content and Format of Labeling for Human Prescription Drug and Biological Products,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

1824. National Center on Minority Health and Health Disparities; Notice of Closed Meeting

NOTICES: National Center on Minority Health and Health Disparities,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

1825. [Docket Nos. FDA-2007-E-0461 (formerly Docket No. 2007E-0424), FDA- 2007-E-0165 (formerly Docket No. 2007E-0425),

NOTICES: LUCENTIS,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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