The Federal Register

Capacity Building Assistance To Improve the Delivery and Effectiveness of Human Immunodeficiency Virus (HIV)

Tue, Dec 2 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: PA 04019.

Catalog of Federal Domestic Assistance Number: 93.943. Key Dates

Letter of Intent Deadline: December 22, 2003.

Application Deadline: January 26, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under Sections 301(a) and 317(k)(2) of the Public Health Service Act, 42 U.S.C. Section 241 and 42 U.S.C. Section 247b(k)(2).

Purpose: The purpose of this announcement is to provide financial assistance to national and regional nongovernmental organizations to provide capacity building assistance (CBA) to communitybased organizations (CBOs) and health departments (HDs) providing HIV prevention services, and to HIV prevention community planning groups (CPGs). These entities are referred to as the ``CBA consumers'' throughout the remainder of this document. This funding will enable the CBA consumers to implement, improve, evaluate, and sustain the delivery of effective human immunodeficiency

Human Immunodeficiency Virus (HIV) Prevention Projects for Community-Based Organizations

Tue, Dec 2 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: 04064.

Catalog of Federal Domestic Assistance Number: 93.939. Key Dates

Letter of Intent Deadline: December 22, 2003.

Application Deadline: February 6, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under sections 301(a) and 317(k)(2) of the Public Health Service Act, [42 U.S.C. 241 and 42 U.S.C. 247b(k)(2)], as amended.

Purpose: The purpose of the program announcement is consistent with CDC's Government Performance and Results Act (GPRA) performance plan and the CDC goal to reduce the number of new HIV infections in the United States. Funds are available under this announcement for HIV prevention projects for CommunityBased Organizations (CBOs).

This program announcement addresses the ``Healthy People 2010'' focus area of HIV Prevention.

Measurable outcomes of this program will be in alignment with one (or more) of the following performance goal(s) for the National Center for HIV,

Youth Violence Prevention Through Community-Level Change

Tue, Dec 2 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: 04054.

Catalog of Federal Domestic Assistance Number: 93.136. Key Dates

Letter of Intent Deadline: January 2, 2004.

Application Deadline: February 17, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under section 391(a) of the Public Health Service Act, [42 U.S.C. section 280b(a), as amended].

Purpose: The purpose of the program is to announce the availability of fiscal year (FY) 2004 funds for a cooperative agreement program for the evaluation of communitylevel interventions to reduce youth violence.

This program addresses the ``Healthy People 2010'' focus area Injury and Violence Prevention.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Injury Prevention and Control (NCIPC): Conduct a targeted program of research to reduce injuryrelated death and disability.

Research Objectives: Youth violence has been li

Medical Devices: Classification of the Dental Sonography Device and Jaw Tracking Device

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA),

Determination of Regulatory Review Period for Purposes of Patent Extension; ELOXATIN

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for ELOXATIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

Determination of Regulatory Review Period for Purposes of Patent Extension; INVANZ

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for INVANZ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

Determination of Regulatory Review Period for Purposes of Patent Extension; LEXAPRO

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined [[Page 67456]]
the regulatory review period for LEXAPRO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

Relative Risk to Public Health From Foodborne Listeria Monocytogenes Among Selected Categories of Ready-to-Eat Foods;

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a document that announced a public meeting to be held on December 4, 2003, in the Federal Register of November 7, 2003 (68 FR 63108). The location of the meeting at the FDA Center for Food Safety and Applied Nutrition Harvey W. Wiley Building in College Park, MD was incorrect. This document corrects that error.

Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.'' This guidance document describes a means by which certain dental sonography and jaw tracking devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify certain types of these devices into class II (special controls).

Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Submissions and Labeling

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; Premarket Submission and Labeling
Recommendations for Drugs of Abuse Screening Tests.'' This draft guidance is intended to assist industry in preparing premarket notification submissions for drugs of abuse screening tests. The draft guidance also provides recommendations regarding the labeling of these tests. This draft guidance is neither final nor is it in effect at this time.

Listeria Monocytogenes Risk Management Action Plan; Availability

Tue, Dec 2 2003 11:00:00 GMT

The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) is announcing the availability of a Listeria monocytogenes risk management action plan. The action plan identifies activities planned by FDA and the Centers for Disease Control and Prevention (CDC) that are targeted to reduce L. monocytogenes associated with illnesses; these activities are intended to help achieve the Healthy People 2010 goal of reducing listeriosis by 50 percent by the year 2005.

Findings of Scientific Misconduct

Tue, Dec 2 2003 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case:

Sheila Blackwell, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB Report), the respondent's admission of responsibility, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Sheila Blackwell, former contractual employee, Department of Pediatrics at UMB, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant 2 R01 MH54983, entitled ``Effectiveness of Standard versus Embellished HIV Prevention.''

Specifically, PHS found that Ms. Blackwell engaged in scientific misconduct by fabricating interview records for the Focus on Teens HIV Risk Prevention Program for nine interviews that had not been performed o

Findings of Scientific Misconduct

Tue, Dec 2 2003 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case:

Khalilah Creek, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB Report), the respondent's admission of responsibility, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Khalilah Creek, former contractual employee, Department of Pediatrics at UMB, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant 2 R01 MH54983, entitled ``Effectiveness of Standard versus Embellished HIV Prevention.''

Specifically, PHS found that Ms. Creek engaged in scientific misconduct by fabricating interview records for the Focus on Teens HIV Risk Prevention Program for eight interviews that had not been performed over the

Findings of Scientific Misconduct

Tue, Dec 2 2003 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case:

Lajuane Woodard, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB Report), the respondent's admission of responsibility, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Lajuane Woodard, former contractual employee, Department of Pediatrics at UMB, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant 2 R01 MH54983, entitled ``Effectiveness of Standard versus Embellished HIV Prevention.''

Specifically, PHS found that Ms. Woodard engaged in scientific misconduct by fabricating interview records for the Focus on Teens HIV Risk Prevention Program for one interview claimed to have been performed in J

Statement of Organization, Functions, and Delegations of Authority

Tue, Dec 2 2003 11:00:00 GMT

Part M of the Substance Abuse and Mental Health Services Administration (SAMHSA) Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services as amended most recently at 68 FR 45264, August 1, 2003, is amended to: revise the functional statements for the Office of the Administrator (OA); and the Office of Policy, Planning and Budget (OPPB) within the Office of the Administrator, and reflect changes in the Division structure within OPPB; and to also revise the functional statements for the Office of Program Services (OPS), and reflect changes in the Division structure within OPS. These organizational changes will more effectively align budget, planning, and
administrative functions; achieve further delayering by restructuring certain divisions, abolishing subordinate branch structures, and reducing the number of supervisory positions; and allow SAMHSA to more effectively use its resources and deploy additional positions to mission suppor

Notice of Listing of Members of the Substance Abuse and Mental Health Services Administration's Senior Executive

Tue, Dec 2 2003 11:00:00 GMT

The Substance Abuse and Mental Health Services Administration (SAMHSA) announces the persons who will serve on the Substance Abuse and Mental Health Services Administration's Performance Review Board. This action is being taken in accordance with Title 5, U.S.C., Section 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals, and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register.

The following persons will serve on the SAMHSA Performance Review Board, which oversees the evaluation of performance appraisals of SAMHSA's Senior Executive Service (SES) members:
James L. Stone, Chairperson,
H. Westley Clark, M.D., J.D., M.P.H,
Daryl W. Kade,

Mark A. Weber.

For further information about the SAMHSA Performance Review Board, contact the Division of Management Systems and Analysis, Substance Abuse and Mental Health S