Department of Health and Human Services April 2006 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 247
Office of the National Coordinator; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the fourth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the fourth meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the fourth meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator: American Health Information Community Meeting; Cancellation and New Meeting Date
This notice announces the fifth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). The April 25, 2006 meeting has been canceled.
Medicare Program; Medicare Graduate Medical Education Affiliation Provisions for Teaching Hospitals in Certain Emergency Situations
This interim final rule with comment period will modify the current Graduate Medical Education (GME) regulations as they apply to Medicare GME affiliations to provide for greater flexibility during times of disaster. Specifically, this rule will implement the emergency Medicare GME affiliated group provisions that will address issues that may be faced by certain teaching hospitals in the event that residents who would otherwise have trained at a hospital in an emergency area (as that term is defined in section 1135(g) of the Social Security Act (the Act)) are relocated to alternate training sites.
Announcement of Availability of Funds for One Family Planning General Training and Technical Assistance Project in Public Health Service Region VI
This announcement seeks applications from public and nonprofit private entities to establish and operate one general training and technical assistance project in Public Health Service (PHS) Region VI (Arkansas, Louisiana, Oklahoma, Texas, and New Mexico). The purpose of the family planning general training program is to ensure that all levels of personnel working in Title X family planning service projects have the knowledge, skills, and abilities necessary for the effective delivery of high quality family planning services. General training also includes specialized technical assistance which consists of specific, specialized or highly skilled family planning training that is usually provided to a single organization based on identified need. The successful applicant will be responsible for the development and overall management of the general training program that provides training for Title X service grantee personnel in PHS Region VI.
Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealers Certificate
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3038, Interstate Shellfish Dealers Certificate.
Regulatory Site Visit Training Program
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER's regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give staff a better understanding of the biologics industry, including its challenges and operations. This notice invites biologics facilities interested in participating in this program to contact CBER for more information.
Draft Guidance for Industry: Center for Biologics and Evaluation Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on July 11, 2001.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements of FDA's regulations requiring that trans fatty acids be declared in the Nutrition Facts panel of conventional foods and dietary supplements on a separate line without a percent Daily Value (%DV).
National Toxicology Program (Ntp); Office of Chemical Nomination and Selection; Announcement of and Request for Public Comment on Toxicological Study Nominations to the NTP
The NTP continuously solicits and accepts nominations for toxicological studies to be undertaken by the program. Nominations of substances of potential human health concern are received from federal agencies, the public, and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. This notice (1) provides brief background information and study recommendations regarding 10 nominations for study by the NTP (Table 1), (2) solicits public comment on the nominations and study recommendations, and (3) requests the submission of additional relevant information for consideration by the NTP in its continued review of these nominations. An electronic copy of this announcement, supporting documents for each nomination, and further information on the NTP and the NTP Study Nomination and Review Process can be accessed through the NTP Web site (https://ntp.niehs.nih.gov/; select ``Nominations to the Testing Program'').
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on March 15, 2000.
Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path.'' FDA is issuing this guidance to inform industry and agency staff of steps that are needed to ensure the safe and effective use of in vitro diagnostic (IVD) devices intended for use in the detection of influenza A (or A/B) virus directly from human specimens. FDA is taking this action because of recent significant public health concerns associated with emergence of an avian influenza A virus strain as a human pathogen in Southeast Asia. This guidance document describes recommendations for fulfilling labeling requirements applicable to all IVDs intended to generally detect influenza A (or A/B) virus directly from human specimens, and outlines the premarket regulatory path for new or modified devices intended to generally detect influenza A virus, or to detect and differentiate, specific novel influenza A viruses infecting humans. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
NIOSH Pilot Study of Truck Driver Anthropometric and Workspace Dimensions; Meeting
Purpose: The public meeting will explain and discuss issues related to the current NIOSH pilot project and a possible large-scale research project on U.S. truck driver anthropometric and workspace data. This possible large-scale study will establish an anthropometric and workspace database for U.S. truck drivers. The database will be used to formulate anthropometric guidelines, develop digital human models for cab designs, and upgrade current standards for new generation cabs that would accommodate all trucking populations. Updated anthropometric information for cab design will help to increase truck drivers' visibility, operational comfort, maneuverability, and post-crash survivability, thereby possibly reducing fatal and nonfatal injuries. The current NIOSH pilot study will (1) identify critical cab design criteria and related human body dimensions, (2) establish test procedures for the large-scale project, and (3) develop research partnerships with interested parties. The scope of this pilot and possible large-scale study will be limited to medium and heavy trucks and their operators in the continental U.S. Special emphasis will be placed on discussion of the following issues: (1) What are the key anthropometric and workspace dimensions for the design of an ergonomically sound cab? (2) What are the essential adjustment parameters and values of the truck buck that is to be constructed for data collection? (3) What are the essential postures to be scanned in three- dimensional anthropometry that are to be used in computer simulation? (4) What are the essential cab accommodation models to be developed once updated anthropometric and workspace data become available? The public is invited to attend and will have the opportunity to provide comments. NIOSH will use this information to assess the scientific basis for the current pilot project and the possible large- scale project on U.S. truck driver anthropometric and workspace data. Status: The consortium meeting will include scientists and representatives from various government agencies, industry and other stakeholders and is open to the public, limited only by the space available. The meeting room accommodates 40 people. Due to limited space, notification of intent to attend the meeting must be made to Jinhua Guan, PhD, not later than April 14, 2006. Dr. Guan can be reached by telephone at (304) 599-4676 or by e-mail at ezg6@cdc.gov. Requests to attend the meeting will be accommodated on a first-come basis. Non-U.S. Citizens: Because of CDC Security Regulations, non-U.S. citizens wishing to attend this meeting must provide the following information in writing to Barbara Phillips (telephone: 304-285-6325; fax: (304) 285-6039; e-mail: djp2@cdc.gov) no later than April 14, 2006: 1. Visitor's Full Name: 2. Gender: 3. Date of Birth: 4. Place of Birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. Visitor's Organization: 11. Organization Address: 12. Organization Telephone Number: 13. Visitor's Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. A copy of the research protocol titled ''NIOSH Pilot Study of Truck Driver Anthropometric and Workspace Dimensions'' can be obtained from the CDC Internet at https://www.cdc.gov/niosh/docs or a hard copy may be requested from the Docket Officer, Karen Dragon (see contact information below).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reprocessed Single-Use Device Labeling
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Reprocessed Single-Use Device Labeling'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration-Regulated Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export Certificates for FDA- Regulated Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Blood Establishment Registration and Product Listing, Form FDA 2830
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Blood Establishment Registration and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public.
Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practice (CGMP) regulations to include new requirements for the label, color, dedication, and design of medical gas containers and closures. These requirements are intended to do the following: Make the contents of medical gas containers more readily identifiable, reduce the likelihood that containers of industrial or other gases would be inappropriately connected to medical oxygen supply systems, and reduce the risk of contamination of medical gases. FDA is also proposing to include medical air, oxygen, and nitrogen among, and exclude cyclopropane and ethylene from, those gases intended for drug use that are exempt from certain labeling requirements.
Announcement of Availability of Funds for Cooperative Agreement to the Arizona Outreach Office to Strengthen Public Health Services at the Arizona-Sonora Border
The Office of Global Health Affairs (OGHA) announces that up to $267,500 in fiscal year (FY) 2006 funds is available for a cooperative agreement to the Arizona Department of Health Services, Arizona Outreach Office of the U.S.-Mexico Border Health Commission to strengthen the binational public health projects and programs along the Arizona-Sonora border. Working in collaboration with the Arizona Department of Health Services Office of Border Health, the Secretaria de Salud de Sonora, and the USMBHC Arizona and Sonora Delegation Offices, this initiative targets activities on the following areas: Data analysis; public information, promotion and communication; and Healthy Gente/Healthy Border 2010 activities. The project will be approved for up to a one-year period for a total of $267,500 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Announcement of Availability of Funds for Cooperative Agreement to the Texas Outreach Office To Strengthen Public Health Services at the Texas-Mexico Border
The Office of Global Health Affairs (OGHA) announces that up to $497,500 in fiscal year (FY) 2006 funds is available for a cooperative agreement to the Texas Department of State Health Services, Outreach Office of the U.S.-Mexico Border Health Commission to strengthen the binational public health projects and programs along the Texas-Mexico border. In collaboration with other Texas Department of State Health Services entities, the Texas Outreach Office will implement and monitor the progress of the Healthy Border 2010 program in the Texas-Mexico border region, work with communities to implement programs to improve the health of border residents, and will publicize the achievements and challenges of border health. The project will be approved for up to a one-year period for a total of $497,500 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.
Announcement of Availability of Funds for Cooperative Agreement to the New Mexico Outreach Office To Strengthen Public Health Services at the New Mexico-Chihuahua Border
The Office of Global Health Affairs (OGHA) announces that up to $345,600 in fiscal year (FY) 2006 funds is available for a cooperative agreement to the New Mexico Department of Health, New Mexico Outreach Office of the U.S.-Mexico Border Health Commission (USMBHC) to strengthen the binational public health projects and programs along the New Mexico-Chihuahua border. This initiative addresses outreach and health promotion activities, evaluation and assessments, health data analysis and surveillance, Healthy Border/Healthy Gente activities, and administrative support to the members and staff of the U.S.-Mexico Border Health Commission. The project will be approved for up to a one-year period for a total of $345,600 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
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.
Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting-May 1 Through May 2, 2006
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the fourth meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the fourth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.
New Animal Drugs; Change of Sponsor; Soluble Bacitracin Methylene Disalicylate and Streptomycin Sulfate Oral Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for bacitracin methylene disalicylate and streptomycin sulfate oral powder from Veterinary Specialties, Inc., to Alpharma Inc.
New Animal Drugs for Use in Animal Feeds; Chlortetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. that provides for a 0-day preslaughter withdrawal time following use of chlortetracycline in cattle feed.
Amendment of February 4, 2004, Order To Embargo Birds and Bird Products Imported From Jordan
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; Indian 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; and Afghanistan on March 21, 2006. On March 23, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Jordan. At this time, HHS/CDC is adding Jordan to its current embargo. This action is effective on March 29, 2006, and will remain in effect until further notice.
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