The Federal Register

Practices To Improve Training Skills of Home Visitors

Mon, Dec 1 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: PA 04053.

Catalog of Federal Domestic Assistance Number: 93.136.

Key Dates: .

Letter of Intent Deadline: December 31, 2003.

Application Deadline: February 19, 2004.

I. Funding Opportunity Description

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

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2004 funds for a cooperative agreement program to conduct a systematic examination of the impact of home visitor training and factors related to the implementation (i.e., competency of visitors providing services, adequate coverage of content according to a prespecified protocol) of an existing efficacious or effective home visiting program on family outcomes of child maltreatment and risk behaviors for youth violence (e.g., poor parent child relations; harsh, lax, or inconsistent discipline

Health Resources and Services Administration

Mon, Dec 1 2003 11:00:00 GMT

Rapid Expansion of Antiretroviral Therapy Programs for HIV
Infected Persons in Selected Countries in Africa and the Caribbean Under the President's Emergency Plan for AIDS Relief

Announcement Type: New.

Funding Opportunity Number: 04080.

Catalog of Federal Domestic Assistance Number: 93.941. [[Page 67187]]

Key Dates: Application Deadline: December 31, 2003. I. Funding Opportunity Description

Authority: This program is authorized under section 301(a) and 307 of the Public Health Service Act, [42 U.S.C. 241(a) and 242l] as amended and under Public Law 10825 (United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601].

Purpose: President Bush's Emergency Plan for AIDS Relief has called for immediate action to turn the tide of HIV/AIDS in Africa and the Caribbean. An important aspect of the President's bold vision is to treat at least two million HIVinfected persons with combination antiretroviral therapy (ART) within five years. This fundi

Rapid Strengthening of Blood Transfusion Services in Selected Countries in Africa and the Caribbean for the

Mon, Dec 1 2003 11:00:00 GMT

Announcement Type: New, Cooperative Agreement.

Funding Opportunity Number: 04077.

Catalog of Federal Domestic Assistance Number: 93.943.

Key Dates:

[sbull] Application Deadline: March 1, 2004.

Executive Summary: An important aspect of the President Bush's Emergency Plan for AIDS Relief is to provide assistance to ensure a safe and adequate blood supply. The focus of this initiative is 14 countries in Africa and the Caribbean heavily affected by HIV/AIDS: Botswana, C[ocirc]te d'Ivoire, Ethiopia, Haiti, Guyana, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zambia. The purpose of this announcement is to rapidly provide support to the Ministries of Health or the Government's National Transfusion Services in the 14 targeted countries, with the goal of developing and implementing a national safe blood program with demonstrable results within the first year of the Emergency Plan. Specific activities include implementation of blood safety programs

Providing Technical Assistance Support for the Rapid Strengthening of Blood Transfusion Services in Selected

Mon, Dec 1 2003 11:00:00 GMT

Announcement Type: New, Cooperative Agreement.

Funding Opportunity Number: 04078.

Catalog of Federal Domestic Assistance Number: 93.943.

Key Dates

[sbull] Application Deadline: March 1, 2004.

Executive Summary: An important aspect of President Bush's Emergency Plan for AIDS Relief plan is to provide
[[Page 67182]]
assistance to ensure a safe and adequate blood supply. The focus of this initiative is 14 countries in Africa and the Caribbean that are heavily affected by HIV/AIDS: Botswana, C[ocirc]te d'Ivoire, Ethiopia, Haiti, Guyana, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zambia. The purpose of this announcement is to provide expert guidance and technical assistance to the Ministries of Health or the National Transfusion Services in the 14 targeted countries as they rapidly develop and implement a national safe blood program with demonstrable results within the first year of the Emergency Plan. An additional intent is to develop susta

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

Mon, Dec 1 2003 11:00:00 GMT

Agency: Centers for Medicare and Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid Services (CMS) (formerly known as the Health Care Financing Administration (HCFA), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

1. Type of Information Collection

Agency Information Collection Activities: Proposed Collection; Comment Request

Mon, Dec 1 2003 11:00:00 GMT

Office of Community Services; Grant to the Concordia Avondale Campus

Mon, Dec 1 2003 11:00:00 GMT

Notice is hereby given that ACF will award grant funds without competition to Concordia Avondale Campus in Chicago, Illinois. This grant is being awarded for a project that conforms to the applicable program objectives, is within legislative authorities, and proposes activities that may be lawfully supported through grant mechanisms. Their grant application is of outstanding and unique merit and presents an opportunity to produce meaningful, sustainable, and useful results in an area of significant interest to ACF.

The Concordia Avondale project will support a twoyear effort to provide social and economic services that support lowincome, working poor and singleparent families in their communities. These services include child care and afterschool programs in the North Center, Lakeview and Ravenswood communities through a sliding scale tuition. The project will be funded at $700,000 for the first year and $800,000 for the second year.

Civil Money Penalties Hearings; Maximum Penalty Amounts and Compliance With the Federal Civil Penalties Inflation

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended.

Dental Devices; Gold Based Alloys, Precious Metal Alloys, and Base Metal Alloys; Designation of Special Controls

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend the classification regulations of goldbased alloys and precious metal alloys for clinical use and base metal alloy devices. FDA is also proposing to exempt these devices from premarket notification and designate a special control for these devices. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug
Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of guidance documents that would serve as special controls for these devices.
[[Page 67098]]

Agency Information Collection Activities; Announcement of OMB Approval; Export of Medical Devices--Foreign Letters of

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export of Medical DevicesForeign Letters of Approval'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of OMB Approval; Agreement for Shipment of Devices for

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Agreement for Shipment of Devices for Sterilization'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for DERAMAXX 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 which claims that animal drug product.

Vulcan Chemicals; Filing of Food Additive Petition

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that Vulcan Chemicals has filed a petition proposing that the food additive regulation for chlorine dioxide be amended to provide for an additional method for producing the additive.

Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys

Mon, Dec 1 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance documents entitled ``Class II Special Controls Guidance Document: Dental Precious Metal Alloys'' and ``Class II Special Controls Guidance Document: Dental Base Metal Alloys.'' These guidance documents describe means by which goldbased alloys and precious metal alloys for clinical use and base metal alloy 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 proposed rule to amend the classification regulations of goldbased alloys and precious metal alloys for clinical use and base metal alloy devices presently classified in class II. In the proposed rule, FDA is also proposing to exempt these devices from premarket notification.

Program Exclusions: October 2003

Mon, Dec 1 2003 11:00:00 GMT

During the month of October 2003, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusions is imposed, no program payment is made to anyone for any items or services (other than an emergency item or service not provided in a hospital emergency room) furnished, ordered or prescribed by an excluded party under the Medicare, Medicaid, and all Federal Health Care programs. In addition, no program payment is made to any business or facility, e.g., a hospital, that submits bills for payment for items or services provided by an excluded party. Program beneficiaries remain free to decide for themselves whether they will continue to use the services of an excluded party even though no program payments will be made for items and services provided by that excluded party. The exclusions have national effect and also apply to all Executive Branch procurement and nonprocurement programs and activities.
Office of Investigation Office of Inspector GeneralD