The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Dec 18 2003 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 4981210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project: NCHS Questionnaire Design Research Laboratory (OMB No. 09200222)RevisionNational Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). The NCHS Questionnaire Design Research Laboratory (QDRL) conducts questionnaire pretesting and evaluation activities for CDC surveys (such as the NCHS National Health Interview Survey) and other federally sponsored surveys. The most common questionnaire evaluati

Opportunity To Collaborate in the Evaluation of Topical Microbicides To Reduce Sexual Transmission of Human

Thu, Dec 18 2003 11:00:00 GMT

The Division of HIV/AIDS Prevention-Surveillance and Epidemiology (DHAPSE) of the National Center of HIV, STD, and TB Prevention (NCHSTP) at the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (DHHS) seeks one or more pharmaceutical, biotechnical, or other companies that hold a proprietary position on agents which may be useful as microbicides to prevent sexual transmission of HIV infection. The selected company and CDC will execute an Agreement under which the company will provide a product for CDC to study the product's safety and preliminary efficacy as a topical microbicide. Initial studies will include invitro assays and may include macaque studies. Agents will be selected for phase I and phase II trials in women and men based upon data obtained in the CDC studies as well as other available published and unpublished safety and efficacy data. Each collaboration would have an expected duration of one (1) to five (5) years. The goals of the collaboration incl

Neurological Devices; Classification of Human Dura Mater

Thu, Dec 18 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Class II Special Controls Guidance Document: Human Dura Mater'' that will serve as the special control for this device. Dates: This rule is effective January 20, 2004.

Advisory Committee Information Hotline

Thu, Dec 18 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of FDA's Advisory Committee Information Hotline.

Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA; Availability

Thu, Dec 18 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: Human Dura Mater.'' This guidance document describes a means
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by which human dura mater 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 this device type into class II (special controls).

AGENCY: Department of Health and Human Services.

Thu, Dec 18 2003 11:00:00 GMT

The Department of Health and Human Services (HHS) is amending its tax refund offset regulation to reflect amendments to 31 U.S.C. 3720A made by tax refund offset provisions of the Debt Collection Improvement Act of 1996 (DCIA). The amended regulation changes the process by which HHS certifies and refers pastdue debt to the Department of Treasury for tax refund offset to satisfy debt owed to the HHS.

Office of Public Health and Science; Statements of Organizations, Functions, and Delegations of Authority

Thu, Dec 18 2003 11:00:00 GMT

Part A, Office of the Secretary (OS) of the Statement of Organization, Functions, and Delegation of Authority for the Department of Health and Human Services (HHS), chapter AC, Office of Public Health and Science (OPHS), as last amended at 67 FR 71568, dated December 2, 2002, is being amended to reflect the realignment of personnel oversight, administration, and management functions for the U.S. Public Health Service (PHS) Commissioned Corps in the OPHS. Specifically, it realigns these functions in a newly established Office of Commissioned Corps Force Management (ACQ) and in the Office of the Surgeon General (ACM). The changes are as follows:

I. Under Part A, Chapter AC, Office of Public Health and Science, make the following changes:

A. Under Paragraph AC.10 Organization, insert the following line at the end of the listing:

N. Office of Commissioned Corps Force Management (ACQ)

B. Under Paragraph AC.20, Functions, make the following changes:

1. Delete Paragraph, ``K. Office of the S

Fiscal Year (FY) 2004 Funding Opportunity

Thu, Dec 18 2003 11:00:00 GMT

The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS), announces the availability of FY 2004 funds for Statewide Consumer Network Grants. A synopsis of this funding opportunity, as well as many other Federal Government funding opportunities, is also available at the Internet site: http://www.grants.gov.

For complete instructions, potential applicants must obtain a copy of the standard Infrastructure Grants Program Announcement (INF04 PA), and the PHS 51611 (Rev. 7/00) application form before preparing and submitting an application. The INF04 PA describes the general program design and provides instructions for applying for all SAMHSA Infrastructure Grants, including Statewide Consumer Network Grants. Additional instructions and requirements specific to Statewide Consumer Network Grants are described below.

Funding Opportun

Fiscal Year (FY) 2004 Funding Opportunity

Thu, Dec 18 2003 11:00:00 GMT

The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS) announces the availability of FY 2004 funds for Statewide Family Network Grants. A synopsis of this funding opportunity, as well as many other Federal Government funding opportunities, is also available at the Internet site: http://www.grants.gov.

For complete instructions, potential applicants must obtain a copy of the standard Infrastructure Grants Program Announcement (INF04 PA), and the PHS 51611 (Rev. 7/00) application form before preparing and submitting an application. The INF04 PA describes the general program design and provides instructions for applying for all SAMHSA Infrastructure Grants, including Statewide Family Network Grants. Additional instructions and requirements specific to the Statewide Family Network Grants are described below.

Funding Opportunity