Department of Health and Human Services April 2006 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 247
Renewal of Agency Information Collection for Indian Self-Determination and Education Assistance Contracts
The Department of the Interior and the Department of Health and Human Services announce a request for comments concerning renewal of OMB Control Number 1076-0136, the Information Collection Request used for Indian Self-Determination and Education Assistance actions. The information collection will be used to process contracts, grants or cooperative agreements for award by the Bureau of Indian Affairs and the Indian Health Service as authorized by the Indian Self- Determination and Education Assistance Act, as amended, and as set forth in 25 CFR part 900. The Department of the Interior and the Department of Health and Human Services invite comment on the information collection described below.
MicroArray Quality Control Project on the Evaluation of Analysis Protocols for Deoxyribonucleic Acid Microarray Data
The Food and Drug Administration (FDA) is soliciting gene expression datasets from deoxyribonucleic acid (DNA) microarray studies, as well as proposals to analyze these datasets in order to evaluate the impact of different analysis protocols on the selection of genes and their associated signatures for biomarker pattern development. This project is being coordinated by FDA as a followup to the MicroArray Quality Control (MAQC) Project. This evaluation process is open to the public.
Vaccine Adverse Event Reporting; Revised Form VAERS-2; Withdrawal of Proposed Revised Form
The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed revised form that was issued in the Federal Register on November 20, 2001.
State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2003; Additional Allotments To Eliminate SCHIP Fiscal Year 2006 Funding Shortfalls; and Provisions for Continued Authority for Qualifying States To Use a Portion of Certain SCHIP Funds for Medicaid Expenditures
This notice with comment period describes the procedure for redistribution of States' unexpended Federal fiscal year (FY) 2003 SCHIP allotments remaining at the end of FY 2005 to those States that fully expended such allotments. This notice also announces the application of the provisions of the Deficit Reduction Act of 2005 (DRA, Pub. L. 109-171, enacted on February 8, 2006) concerning the availability of additional allotments appropriated to eliminate States' funding shortfalls under the SCHIP in FY 2006. The redistributed FY 2003 allotments and the additional allotments to eliminate shortfalls in FY 2006 will be available through the end of FY 2006 (September 30, 2006). This notice also describes the DRA amendments to the SCHIP statute relating to the provisions for ``qualifying States'' to elect to receive a portion of their available SCHIP allotments as increased Federal matching funds for certain expenditures in their Medicaid programs.
New Animal Drugs for Use in Animal Feeds; Melengestrol and Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and monensin to make two-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of June 2, 2006, for the direct final rule that appeared in the Federal Register of December 2, 2005 (70 FR 72197). The direct final rule removes the regulation applicable to the status of specific products; Group A streptococcus. FDA is removing the regulation because the existing requirement for Group A streptococcus organisms and derivatives is both obsolete and a perceived impediment to the development of Group A streptococcus vaccines. This document confirms the effective date of the direct final rule.
Medicare Program; Requirements for Providers and Suppliers To Establish and Maintain Medicare Enrollment
This final rule requires that all providers and suppliers (other than physicians or practitioners who have elected to ``opt-out'' of the Medicare program) complete an enrollment form and submit specific information to us. This final rule also requires that all providers and suppliers periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. In addition, this final rule implements provisions in the statute that require us to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. These statutory provisions include requirements meant to protect beneficiaries and the Medicare Trust Funds by preventing unqualified, fraudulent, or excluded providers and suppliers from providing items or services to Medicare beneficiaries or billing the Medicare program or its beneficiaries.
Exotic Animal Importation, Sale, and Distribution Discussions; Notice of Public Meeting
This notice announces a public meeting on the subject of the importation, sale, and distribution of exotic animals. The purpose of the meeting is to gather information and discuss issues and concerns related to infectious disease threats associated with the importation, sale, and distribution of exotic animals.
National Toxicology Program (NTP); Liaison and Scientific Review Office; Meeting of the NTP Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the Director for the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Proposed Collection; Comment Request; ODS Assessment of Dietary Supplement Education
The proposed information collection described below will be submitted to the Office of Management and Budget (OMB) for review and approval, as required by the Paperwork Reduction Act of 1995. In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act, for opportunity for public comment on proposed data collection projects, the Office of Dietary Supplements (ODS), at the National Institutes of Health (NIH) is soliciting public comments on the subject proposal.
Family Violence Prevention and Services/Grants for Battered Women's Shelters/Grants to Native American Tribes (Including Alaska Native Villages) and Tribal Organizations
This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to Native American Tribes (including Alaska Native Villages) and Tribal organizations. The purpose of these grants is to assist Tribes in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2006. Grantees are to be mindful that although the expenditure period for grants is a two-year period, an application is required every year to provide continuity in the provision of services. (See Section II. Award Information, Expenditure Periods.)
Preparation for International Conference on Harmonization Meetings in Yokohama, Japan; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan on June 5 through 8, 2006, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Monday, May 8, 2006, from 9:30 a.m. to 12:30 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Maryland Conference Room, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 9:25 a.m., as you will be escorted from the front entrance of 5600 Fishers Lane to the Maryland Conference Room. Contact Person: All participants must register with Sema Hashemi, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, e-mail: Sema.Hashemi@fda.hhs.gov or FAX: 301-480-0716. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by May 1, 2006. If you need special accommodations due to a disability, please contact Sema Hashemi at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.
Revision of Final Fiscal Year (FY) 2006 State Allotment of Community Mental Health Services (CMHS) Block Grant (BG)
SAMHSA has revised the final FY 2006 calculations for the CMHS BG 50 States and Washington, DC after it has been discerned that the July 1, 2003 population estimates used in the calculation involved multiple counting of persons who reported more than one race. This notice describes the background and rationale for revising the calculations and presents a revised set of State-specific final FY 2006 CMHS BG allotment figures, showing the differences in the two sets of calculations.
Decision To Evaluate a Petition to Designate a Class of Employees at the Feed Materials Production Center (FMPC), Fernald, OH
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Feed Materials Production Center (FMPC), Fernald, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Feed Materials Production Center (FMPC), Fernald, Ohio. Location: All locations. Job Titles and/or Job Duties: All employees of the Department of Energy (DOE), DOE contractors and subcontractors. Period of Employment: January 1, 1951 through December 31, 1989.
Summary of Special Exposure Cohort Petitions and National Institute for Occupational Safety and Health Findings
Pursuant to the requirements of 42 CFR 83.15(a), the Department of Health and Human Services (HHS) gives notice of petitions to add classes of employees to the Special Exposure Cohort (SEC) and the findings of the National Institute for Occupational Safety and Health (NIOSH) from evaluating these petitions that are to be considered by the Advisory Board on Radiation and Worker Health April 25-27, 2006 (see notice: Federal Register/Vol. 71, No. 66/Thursday, April 6, 2006/Notices, p. 17470). Summary of petitions and NIOSH findings:
Amendment of February 4, 2004, Order To Embargo Birds and Bird Products Imported From Burkina Faso
On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/ [H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 FR 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; and Jordan on March 29, 2006. On April 3, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in guinea fowl in Burkina Faso. USDA added Burkina Faso to their ban on April 5, 2006. At this time, HHS/CDC is adding Burkina Faso to its current embargo. This action is effective on April 10, 2006, and will remain in effect until further notice.
Amendment of February 4, 2004, Order To Embargo Birds and Bird Products Imported From Pakistan
On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/ [H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 FR 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; Jordan on March 29, 2006; and Burkina Faso on April 10, 2006. On April 4, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Pakistan. At this time, HHS/CDC is adding Pakistan to its current embargo. This action is effective on April 10, 2006, and will remain in effect until further notice.
Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 9.'' This guidance document is intended to assist facilities and their personnel in meeting the Mammography Quality Standards Act (MQSA) final regulations.
Nominations Requested/Open for the 2006 Secretary's Innovation in Prevention Awards
The Department of Health and Human Services (HHS) seeks nominations of public and private sector organizations to receive the 2006 Secretary's Innovation in Prevention Awards Initiative. This activity is part of a broader Departmental initiative called Steps to a Healthier U.S. that advances President George W. Bush's HealthierUS goal of helping Americans live longer, better and healthier lives. The statutory authority for this health promotion activity is Section 1703 (42 U.S.C. 300u-2) from Title XVII of the Public Health Service Act. The Secretary's Innovation in Prevention Awards Initiative will identify and celebrate outstanding organizations that have implemented innovative and creative chronic disease prevention and health promotion programs. To be nominated, a program must address at least one of the following risk factors: (1) Obesity; (2) Physical activity; and (3) Nutrition. The Department intends that these awards will provide an opportunity to increase public awareness of creative approaches to develop and expand innovative health programs and duplication of successful strategies. Awards will be given in the following categories: Faith-Based and Community Initiatives Health Care Delivery Healthy Workplace Large Employer >500 employees Small Employer
Agency for Healthcare Research and Quality; Meeting of the Citizens' Health Care Working Group
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.
Meeting of the Advisory Committee on Blood Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that a meeting has been scheduled for the Advisory Committee on Blood Safety and Availability (ACBSA).
Office of Planning, Research and Evaluation Grant to Rutgers, the State University of New Jersey
Notice is hereby given that the Office of Planning, Research and Evaluation will award grant funds without competition to Rutgers, the State University of New Jersey (National Marriage Project). This grant is being awarded for an unsolicited proposal entitled, ``Cohabitation, Marriage and Child Well-Being: A Cross-National Analysis'' that conforms to the applicable program objectives, is within the legislative authorities and proposes activities that may be lawfully supported through grant mechanisms. The study is unique, timely, and highly relevant to ACF's interest in supporting healthy marriage. A compilation and analyses of the information from developed foreign nations regarding cohabitation is likely to be informative, instructive, and beneficial to United States' policymakers and others interested in family policy. The National Marriage Project within Rutgers, the State University of New Jersey, is well-positioned to conduct a comparative analysis of cohabitation across developed nations and the United States. The National Marriage Project at Rutgers University is a nonpartisan organization devoted to creating greater pubic awareness about the importance of marriage as a child-rearing institution. The grant will support a 12-month project at a cost of $86,308 in Federal support. The project is also being supported through non- Federal funding sources.
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