Department of Health and Human Services February 3, 2005 – Federal Register Recent Federal Regulation Documents

National Institute for Occupational Safety and Health; Advisory Board on Radiation and Worker Health
Document Number: 05-2201
Type: Notice
Date: 2005-02-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 05-2139
Type: Notice
Date: 2005-02-03
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Advisory Committee on Infant Mortality; Notice of Meeting
Document Number: 05-2102
Type: Notice
Date: 2005-02-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
Food and Drug Administration Drug Educational Forum; Public Workshop
Document Number: 05-2098
Type: Notice
Date: 2005-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), is announcing a public workshop entitled ``FDA Drug Educational Forum.'' This public workshop is intended to provide information about FDA's premarket requirements to the drug industry, particularly small businesses, startups, and entrepreneurs. Date and Time: The public workshop will be held on May 11, 2005, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Kansas City Health Department Auditorium, 2400 Troost Ave., Kansas City, MO 64108- 2666. For directions to the facility, please call 816-513-6008, e-mail: health@kcmo.org, or visit https://www.kcmo.org/health.nsf/web/ healthmap?opendocument. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: David Arvelo or Cassandra Davis, Food and Drug Administration, 4040 N. Central Expressway, suite 900, Dallas, TX 75204-3128, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail: oraswrsbr@ora.fda.gov. Registration: Registration begins on April 6, 2005, and ends May 6, 2005. Registration is free. Seats are limited, please register as soon as possible. Space will be filled in order of receipt of registration. Those registered will receive confirmation. Registration will close after available space fills. Registration at the site will be based on space availability on the day of the event starting at 8 a.m. If you need special accommodations due to disability, please contact David Arvelo or Cassandra Davis (see CONTACT) at least 7 days in advance. Registration Form Instructions: To register, complete the following registration form and submit via: E-mail: oraswrsbr@ora. fda.gov, FAX: 214-253-4970, or Mail to: Food and Drug Administration, Southwest Regional Office, Small Business Representative, 4040 N. Central Expressway, suite 900, Dallas, TX 75204-3128. Name: Company Name: Mailing Address: City: State: Zip Code: Phone: ( ) Fax: ( ) E-mail: ( ) Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts 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 public workshop at cost of 10 cents per page.
Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
Document Number: 05-2094
Type: Notice
Date: 2005-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing a public hearing on the current practice of applying color to pharmaceutical product packaging and labeling to help identify, classify, and differentiate those drug products. To date, there is little scientific evidence that applying color is effective in reducing medication errors. Furthermore, there is no validated scientific method to corroborate the benefits of using colors on pharmaceuticals in this fashion. FDA does not have a policy pertaining to the use of colors on drug product packaging. The purpose of the hearing is to obtain public input on the benefits and potential drawbacks of applying color to drug packaging and labeling to help identify, classify, or differentiate those products.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 05-2074
Type: Notice
Date: 2005-02-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Cooperative Agreement Program for the National Academic Centers of Excellence on Youth Violence Prevention; Notice of Availability of Funds-Amendment
Document Number: 05-2044
Type: Notice
Date: 2005-02-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Community-Based Interventions for Alcohol-Impaired Driving; Notice of Availability of Funds-Amendment
Document Number: 05-2043
Type: Notice
Date: 2005-02-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft Acute Injury Care Research Agenda for Public Comment and Recommendations
Document Number: 05-2041
Type: Notice
Date: 2005-02-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the availability of the Draft Acute Injury Care Research Agenda for the National Center for Injury Control and Prevention (NCIPC) and solicits comments during the public comment period of February 3, 2005, through March 3, 2005. In June 2002, NCIPC released its current Injury Research Agenda, which outlines the Center's injury research direction through 2007. The NCIPC Research Agenda highlights seven key injury research areas: Injuries at home and in the community, recreation, transportation, violence, suicide, youth violence, and acute care, disability, and rehabilitation. The NCIPC Research Agenda was being completed when the events of September 11, 2001, occurred; that event led NCIPC to revisit the agenda and see what, if any, gaps existed and needed to be addressed. This analysis revealed that out of the thirteen priority areas for research in the area of acute care, disability, and rehabilitation, only three dealt specifically with acute injury care. Recognizing this limited focus, the NCIPC decided to supplement the current research agenda by extending the acute injury care portion of the agenda, focusing on the intersection between public health and acute injury care research. Over the past year, NCIPC has been developing an Acute Injury Care Research Agenda based on input from external experts in the field of acute injury care (e.g., emergency medical services, emergency medicine, trauma surgery, public health), Federal partners, and internal staff. The objectives presented will be appended to the acute care section of the NCIPC Research Agenda. The proposed six research objectives and four infrastructure objectives are as follows: Research Objectives
Collaborative Efforts To Prevent Child Sexual Abuse
Document Number: 05-2039
Type: Notice
Date: 2005-02-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Youth Violence Prevention Through Community-Level Change; Notice of Availability of Funds-Amendment
Document Number: 05-2038
Type: Notice
Date: 2005-02-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services
Document Number: 05-2029
Type: Rule
Date: 2005-02-03
Agency: Department of Health and Human Services
The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.
Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates, Policy Changes, and Clarification
Document Number: 05-1901
Type: Proposed Rule
Date: 2005-02-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The payment amounts and factors used to determine the updated Federal rates that are described in this proposed rule have been determined based on the LTCH PPS rate year July 1, 2005 through June 30, 2006. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and would continue to be effective each October 1. The proposed outlier threshold for July 1, 2005 through June 30, 2006 is also derived from the LTCH PPS rate year calculations. We are proposing to adopt new labor market area definitions for the purpose of geographic classification and the wage index. We are also proposing policy changes and clarifications.
Administration for Native Americans (ANA); FY 2005 for New Community-Based Projects
Document Number: 05-1900
Type: Notice
Date: 2005-02-03
Agency: Administration for Children and Families, Department of Health & Human Services, Children and Families Administration, Department of Health and Human Services
The Administration for Native Americans (ANA), within the Administration for Children and Families, announces the availability of fiscal year (FY) 2005 funds for new community-based projects under ANA's Social and Economic Development Strategies (SEDS) for Native Americans program. ANA's FY 2005 SEDS goals and areas of interest are focused on strengthening children, families, and communities through community-based organizations, tribes, and Village governments. The Program Areas of Interest are projects that ANA considers supportive to Native American communities. Although eligibility for funding is not restricted to projects of the type listed in this program announcement, these Areas of Interest are ones which ANA sees as particularly beneficial to the development of healthy Native American communities. Financial assistance under the SEDS program is provided utilizing a competitive process in accordance with the Native American Programs Act of 1974, as amended. The purpose of this Act is to promote the goal of economic and social self-sufficiency for American Indians, Native Hawaiians, Alaskan Natives, and other Native American Pacific Islanders, including American Samoa natives.
Administration for Native Americans (ANA); FY 2005 Funds for New Community-Based Activities
Document Number: 05-1899
Type: Notice
Date: 2005-02-03
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Native Americans (ANA), within the Administration for Children and Families, announces the availability of fiscal year (FY) 2005 funds for new community-based activities under ANA's Native Language program. Financial assistance is provided utilizing a competitive process in accordance with the Native American Programs Act of 1974, as amended. ANA provides financial assistance to eligible applicants for the purpose of assisting Native Americans in assuring the survival and continuing vitality of their languages. Grants are provided under the following two categories: Category I Assessment Grants are used to conduct the assessment needed to identify the current status of the Native American language(s) to be addressed and to establish community long-range language goals; and, Category II Design and/or Implementation Grants are to design and/or implement a preservation language project that will contribute to the achievement of the community's long-range language goal(s). The Program Areas of Interest are projects that ANA considers supportive to Native American communities. Although eligibility for funding is not restricted to projects of the type listed in this program announcement, these Areas of Interest are ones which ANA sees as particularly beneficial to the development of healthy Native American communities.
Administration for Native Americans (ANA); FY 2005 Funds for the Environmental Regulatory Enhancement Program
Document Number: 05-1898
Type: Notice
Date: 2005-02-03
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Native Americans (ANA), within the Administration for Children and Families, announces the availability of fiscal year (FY) 2005 funds for the Environmental Regulatory Enhancement (Environmental) Program. Financial assistance is provided utilizing the competitive process in accordance with the Native American Programs Act of 1974, as amended. The Program Areas of Interest are projects that ANA considers supportive to Native American communities. Although eligibility for funding is not restricted to projects of the type listed in this program announcement, these Areas of Interest are ones which ANA sees as particularly beneficial to the development of healthy Native American communities.
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