The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Jun 13 2008 11:00:00 GMT

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 Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046395960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collecte

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

Fri, Jun 13 2008 11:00:00 GMT

Medicare Program; Public Meeting in Calendar Year 2008 for New Clinical Laboratory Tests Payment Determinations

Fri, Jun 13 2008 11:00:00 GMT

This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2009, which will be effective on January 1, 2009. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting.

Medical Devices; Medical Device Reporting; Baseline Reports

Fri, Jun 13 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.

Oral Dosage Form New Animal Drugs; Deracoxib

Fri, Jun 13 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 50milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs.

Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and Praziquantel Tablets

Fri, Jun 13 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.

Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule

Fri, Jun 13 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is proposing to remove the requirement for baseline reports. The removal of this requirement would eliminate unnecessary duplication and reduce the manufacturer's reporting burden. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

National Center for Research Resources; Notice of Closed Meeting

Fri, Jun 13 2008 11:00:00 GMT

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 Center for Research Resources, Special Emphasis Panel, SNP SEP.

Date: July 16, 2008.

Time: 1 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

Contact Person: John R. Glowa, PhD, Scienti

National Heart, Lung, and Blood Institute; Notice of Closed Meeting

Fri, Jun 13 2008 11:00:00 GMT

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.

Name of Committee: National Heart, Lung, and Blood Institute, Special Emphasis Panel, NRSA ShortTerm Research Training (T35's).

Date: July 2, 2008.

Time: 2 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Rockledge Two, 6701 Rockledge Drive Room 7186, Bethesda, MD 20892 (Telephone Conference Call).

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