The Federal Register

Privacy Act of 1974; Report of a Modified or Altered System of Records

Mon, Dec 19 2005 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, titled ``NonMedicare Beneficiary Workers' Compensation (WC) Setaside File (WCSAF),'' System No. 09700537, last published at 67 FR 36892 (May 28, 2002). We propose to expand the scope of this system to include nonMedicare beneficiaries whose applications for a WC Arrangement have not been approved (denied) as submitted. The disclosure provisions contained in published routine use number 2 and 3 are deemed to be duplicative of each other and as such require corrective action. This modified routine use will now be number 2 and will authorize disclosure to ``another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent.''

We are modifying the language in the remaining routine uses to provide clarity to CMS's intention to disclose individualspecific information contained in this system. The routine uses will then be prio

Proposed Information Collection Activity; Comment Request

Mon, Dec 19 2005 11:00:00 GMT

Proposed Projects

Title: Sanction Policies Task Order.

OMB No.: New Collection.

Description: This study is designed to determine how local welfare offices implement sanction policies in the Temporary Assistance for Needy Families program. This study will survey local welfare staff to gather indepth qualitative information on how workers interpret the policies and apply them in specific instances. The results of this study should give the Administration for Children and Families (ACF) a better understanding of possible outcomes of various sanction policies, which in turn will help ACF design a research program to study the effect of sanctions.

Respondents: A maximum of 324 welfare staff in local welfare offices.
Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden

Oral Dosage Form New Animal Drugs; Moxidectin Gel; Moxidectin and Praziquantel Gel

Mon, Dec 19 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs provide for oral use of moxidectin gel or moxidectin and praziquantel gel in horses and ponies for the treatment and control of two additional species of small strongyles.

New Animal Drugs; Change of Sponsor; Tiamulin

Mon, Dec 19 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for four approved new animal drug applications (NADAs) for oral dosage forms and feed uses of tiamulin from Boehringer Ingelheim Vetmedica, Inc., to Novartis Animal Health US, Inc.

Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review

Mon, Dec 19 2005 11:00:00 GMT

The Food and Drug Administration (FDA) proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the U.S. District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004 (69 FR 78281). The purpose of this final rule and final order is to amend the biologics regulations, issue a final order in response to the report and recommendations of the Panel; and, respond to comments on the previously published proposed rule and proposed order submitted to the Division of Dockets Management. This final rule and final order does not addres

Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed;

Mon, Dec 19 2005 11:00:00 GMT

The Food and Drug Administration (FDA) proposed, among other things, to classify Anthrax Vaccine Adsorbed (AVA) on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the United States District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004. The purpose of this final order is to categorize AVA according to the evidence of its safety and effectiveness, thereby determining if it may remain licensed and on the market; issue a final response to recommendations made in the Panel's report, and; respond to comments on the previously published proposed order. The final rule and final order concerning bacterial vaccines and tox

Clinical Studies of Safety and Effectiveness of Orphan Products; Availability of Grants; Request for Applications

Mon, Dec 19 2005 11:00:00 GMT

I. Funding Opportunity Description

The Food and Drug Administration (FDA) is announcing changes to its Office of Orphan Products Development (OPD) grant program for fiscal year (FY) 2007 and FY 2008. This announcement supersedes the previous announcement of this program, which was published in the Federal Register of January 14, 2005 (70 FR 2642). Please note that there is only one receipt date for FY 2007 and one receipt date for FY 2008. 1. Background

OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people per year.

2. Program Research Goals

The goal of FDA's OPD grant program is to support the clinical development o

Findings of Scientific Misconduct

Mon, Dec 19 2005 11:00:00 GMT

Notice is hereby given that on November 23, 2005, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the scientific misconduct findings of the U.S. Public Health Service (PHS) in the following case:

Jessica Lee Grol, University of Pittsburgh: Based on the report of an investigation conducted by the University of Pittsburgh (UP) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, HHS found on October 17, 2005, that Ms. Grol, former Research Project Coordinator, Department of Neurological Surgery, UP, engaged in
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scientific misconduct by fabricating study research records for 15 subjects, including the patient interview data, the forms tracking data, and the medical record extraction data in a study on the management of cerebral aneurysms. The research was supported by National Institute of Neurological Disorders and Stroke (NINDS), N

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

Mon, Dec 19 2005 11:00:00 GMT

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)4431129.

The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:
Proposed Project: The Sentinel Centers Network (SCN) Core Data Set (OMB No. 09150268)Extension

HRSA's Bureau of Primary Health Care (BPHC) established the Sentinel Centers Network (SCN) to assist in addressing critical quality, programmatic, and policy issues. Health centers identified as having adequate infrastructure and commitment through the competitive contract process have generated data for quality and program analyses and for projects on topics that have immed

Loan Repayment Program for Repayment of Health Professions Educational Loans

Mon, Dec 19 2005 11:00:00 GMT

Announcement Type: Initial.

CFDA Number: 93.164.

Key Dates: Beginnning of 2006 Award Period: January 20, 2006; Ending of 2006 Award Period: September 30, 2006.

1. Funding Opportunity Description

The Indian Health Service (IHS) estimated budget request for Fiscal Year (FY) 2006 includes $11,698,754 for the Indian Health Service (IHS) Loan Repayment Program (LRP) for health professional educational loans (undergraduate and graduate) in return for fulltime clinical service in Indian health programs.

This program announcement is subject to the appropriation of funds. This notice is being published early to coincide with the recruitment activity of the IHS, which competes with other Government and private health management organizations to employ qualified health professionals.

This program is authorized by Section 108 of the Indian Health Care Improvement Act (IHCIA) as amended, 25 U.S.C. 1601 et.seq. The IHS invites potential applicants to request an application for participa